Eli Lilly and Company is a global pharmaceutical firm dedicated to discovering, developing, and delivering innovative medicines that improve patient outcomes worldwide. Their ultimate mission is to make life better for people around the globe through high-quality healthcare solutions. The purpose of the company is to create medicines that help people live longer, healthier, and more active lives, while maintaining a commitment to ethical standards, scientific excellence, and integrity in all their operations.

Manufacturing & Electronics

Lilly

We're a medicine company turning science into healing to make life better for people around the world.

You need a science-related degree or equivalent experience, quality systems knowledge, effective communication, project management skills, and experience in quality control or assurance.

You will manage quality systems, provide consultation, oversee audits, ensure compliance, drive improvements, support training, and collaborate with business areas on quality-related initiatives.

Healthcare

Cork

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our
 work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly
 Cork and beyond.
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 <h2 class="jobSectionHeader"> Implement and Manage Quality Systems </h2>
 <ul>
 <li>Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.</li>
 <li>Recommends new quality system documents or changes to existing quality system documents where applicable.</li>
 <li>Advise on appropriate training for implementation and documentation.</li>
 <li>Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.</li>
 <li>Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.</li>
 <li>Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.</li>
 <li>Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.</li>
 <li>Complete self-inspections and drive improvements that are meaningful and actionable</li>
 <li>Ensure local implementation of the quality systems as necessary.</li>
 <li>Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.</li>
 </ul>
 
 <h2 class="jobSectionHeader"> Provide Quality Oversight for business area(s)</h2>
 <ul>
 <li>Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.</li>
 <li>Communicates and escalates to management as appropriate.</li>
 <li>Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.</li>
 <li>Provide updates to quality and business owners.</li>
 <li>Seek and implement simplification and process improvement.</li>
 <li>Coordinate quality improvement initiatives.</li>
 <li>Review metrics and trending to improve processes and compliance, as assigned.</li>
 <li>Compile compliance metrics and maintain metrics process (for example, periodic report metrics).</li>
 <li>Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).</li>
 <li>Monitor completion of deviations, change controls, CAPA, audit responses</li>
 </ul>
 
 Audits and Inspections 
 <ul>
 <li>Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).</li>
 <li>Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)</li>
 <li>Ensure completion of audit corrective action plans and timely resolution.</li>
 <li>Leads and/or supports readiness activities in collaboration with business partners.</li>
 </ul>
 
 <h2 class="jobSectionHeader"> Partnership with other area(s) </h2>
 <ul>
 <li>Functions as the initial point of consultation for business areas on quality related questions.</li>
 <li>Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.</li>
 <li>Shares key learning to drive simplification and replicate best practices</li>
 <li>Collaborates with other quality groups as appropriate and develops quality network.</li>
 <li>Establishes good working relationships with assigned business area(s).</li>
 <li>Actively participates in team, business and quality related meetings.</li>
 <li>Supports issue resolution including escalation.</li>
 <li>Utilize a risk-based approach in guiding business areas.</li>
 <li>Support key projects as assigned.</li>
 <li>Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.</li>
 <li>Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.</li>
 <li>Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.</li>
 <li>Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.</li>
 <li>Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.</li>
 </ul>
 
 <h2 class="jobSectionHeader"> Minimum Qualification Requirements</h2>
 <ul>
 <li>Bachelor’s Degree in a science/technology/health care related field or equivalent work experience</li>
 <li>Demonstrated ability to apply quality systems within a regulated work environment</li>
 <li>Effective project and time management skills</li>
 <li>Demonstrated ability to communicate effectively, both written and verbal, and to influence others</li>
 <li>Demonstrated ability to prioritize and handle multiple concurrent tasks</li>
 <li>Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies</li>
 <li>Strong interpersonal skills with demonstrated flexibility in varying environments/geographies</li>
 <li>Effective organization/self-management skills</li>
 </ul>
 
 <h2 class="jobSectionHeader"> Other Information/Additional Preferences</h2>
 <ul>
 <li>Experience in a quality control/quality assurance role</li>
 <li>Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.</li>
 <li>Knowledge of quality systems</li>
 <li>Ability to work independently and as part of a team</li>
 <li>Demonstrated ability to work in a global environment</li>
 </ul>
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
</div>


 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our
 work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly
 Cork and beyond.
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
  Implement and Manage Quality Systems 
 
  Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.
  Recommends new quality system documents or changes to existing quality system documents where applicable.
  Advise on appropriate training for implementation and documentation.
  Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
  Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
  Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
  Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
  Complete self-inspections and drive improvements that are meaningful and actionable
  Ensure local implementation of the quality systems as necessary.
  Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
 
 
  Provide Quality Oversight for business area(s)
 
  Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.
  Communicates and escalates to management as appropriate.
  Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.
  Provide updates to quality and business owners.
  Seek and implement simplification and process improvement.
  Coordinate quality improvement initiatives.
  Review metrics and trending to improve processes and compliance, as assigned.
  Compile compliance metrics and maintain metrics process (for example, periodic report metrics).
  Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions (for example, PRAC assessment reports).
  Monitor completion of deviations, change controls, CAPA, audit responses
 
 
  Audits and Inspections 
 
  Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
  Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
  Ensure completion of audit corrective action plans and timely resolution.
  Leads and/or supports readiness activities in collaboration with business partners.
 
 
  Partnership with other area(s) 
 
  Functions as the initial point of consultation for business areas on quality related questions.
  Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.
  Shares key learning to drive simplification and replicate best practices
  Collaborates with other quality groups as appropriate and develops quality network.
  Establishes good working relationships with assigned business area(s).
  Actively participates in team, business and quality related meetings.
  Supports issue resolution including escalation.
  Utilize a risk-based approach in guiding business areas.
  Support key projects as assigned.
  Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
  Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.
  Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
  Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.
  Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.
 
 
  Minimum Qualification Requirements
 
  Bachelor’s Degree in a science/technology/health care related field or equivalent work experience
  Demonstrated ability to apply quality systems within a regulated work environment
  Effective project and time management skills
  Demonstrated ability to communicate effectively, both written and verbal, and to influence others
  Demonstrated ability to prioritize and handle multiple concurrent tasks
  Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
  Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
  Effective organization/self-management skills
 
 
  Other Information/Additional Preferences
 
  Experience in a quality control/quality assurance role
  Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.
  Knowledge of quality systems
  Ability to work independently and as part of a team
  Demonstrated ability to work in a global environment
 
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly


Sr. Associate/ Principal Associate - Medicines Quality Organization - Lilly

Sr. Associate/ Principal Associate - Medicines Quality Organization

You need finance experience, an associate degree (or equivalent), fluency in English, attention to detail, strong analytical skills, and effective communication in a compliance-driven global team.

You will manage clinical trial payments, resolve invoice issues, liaise with vendors, ensure compliance with regulations, and support continuous improvement efforts while adapting to changing priorities.

People, HR & Administration

Accounting & Tax

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered.
 
 Path/Level:
 P1-P3
 Note: Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.
 
 At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 
 Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 This is a permanent position.
 Responsibilities
 Act as SME for the purchase to pay process for clinical trial investigator payments, including:
 <ul>
 <li>Vendor creation and management</li>
 <li>PO creation and maintenance</li>
 <li>Identify, communicate, and resolve site issues</li>
 <li>Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems</li>
 <li>Understand and comply with procurements, legal and financial requirements and procedures</li>
 <li>Issue resolution related to rejected invoices</li>
 <li>Vendor follow up where invoices have not been received</li>
 <li>Identify, communicate, and resolve issues</li>
 <li>Liaise with 3rd party to maintain operational relationship</li>
 <li>Anticipate and monitor dynamically changing priorities</li>
 <li>Provide feedback and shared learning for continuous improvement</li>
 <li>Assist the teams with reviewing and ensuring that SOP, Job Aids, Flowcharts &amp; Ref Documents are up to date.</li>
 </ul>
 
 Minimum Qualifications
 <ul>
 <li>Experience in a finance function</li>
 <li>Associate degree (or equivalent work experience)</li>
 <li>Fluency in English is essential for this role.</li>
 <li>Ability to learn and comply with financial and legal guidelines and policies (budget and contract)</li>
 <li>Appreciation of / experience in compliance-driven environment</li>
 </ul>
 
 Additional Skills
 <ul>
 <li>Ability to handle complexity and utilize analytical skills, with attention to detail</li>
 <li>Ability to effectively prioritize and complete key tasks and deliverables</li>
 <li>Ability to both actively listen and effectively communicate</li>
 <li>Ability to work in global team environment and communicate effectively with both internal business partners of all levels &amp; disciplines as well as external partners and vendors.</li>
 </ul>
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
</div>


 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered.
 
  Path/Level:
 P1-P3
  Note: Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.
 
  At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 
 Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 This is a permanent position.
  Responsibilities
 Act as SME for the purchase to pay process for clinical trial investigator payments, including:
 
  Vendor creation and management
  PO creation and maintenance
  Identify, communicate, and resolve site issues
  Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  Understand and comply with procurements, legal and financial requirements and procedures
  Issue resolution related to rejected invoices
  Vendor follow up where invoices have not been received
  Identify, communicate, and resolve issues
  Liaise with 3rd party to maintain operational relationship
  Anticipate and monitor dynamically changing priorities
  Provide feedback and shared learning for continuous improvement
  Assist the teams with reviewing and ensuring that SOP, Job Aids, Flowcharts & Ref Documents are up to date.
 
 
  Minimum Qualifications
 
  Experience in a finance function
  Associate degree (or equivalent work experience)
  Fluency in English is essential for this role.
  Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  Appreciation of / experience in compliance-driven environment
 
 
  Additional Skills
 
  Ability to handle complexity and utilize analytical skills, with attention to detail
  Ability to effectively prioritize and complete key tasks and deliverables
  Ability to both actively listen and effectively communicate
  Ability to work in global team environment and communicate effectively with both internal business partners of all levels & disciplines as well as external partners and vendors.
 
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly


Sr Associate - Trial Capabilities Finance - Lilly

Sr Associate - Trial Capabilities Finance

You need finance experience, an associate degree or equivalent, fluency in English, and the ability to learn compliance with financial/legal guidelines in a compliance-driven environment.

You will manage vendor processes for clinical trial payments, resolve invoice issues, ensure compliance with regulations, and maintain operational relationships with third parties while supporting continuous improvement.

Business, Operations & Strategy

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered.
 
 Path/Level:
 P1-P3
 Note: Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.
 
 At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 
 Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 This is a permanent position with a hybrid workplace where you will be expected to attend the office 50% of the time.
 
 Responsibilities
 Act as SME for the purchase to pay process for clinical trial investigator payments, including:
 <ul>
 <li>Vendor creation and management</li>
 <li>PO creation and maintenance</li>
 <li>Identify, communicate, and resolve site issues</li>
 <li>Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems</li>
 <li>Understand and comply with procurements, legal and financial requirements and procedures</li>
 <li>Issue resolution related to rejected invoices</li>
 <li>Vendor follow up where invoices have not been received</li>
 <li>Identify, communicate, and resolve issues</li>
 <li>Liaise with 3rd party to maintain operational relationship</li>
 <li>Anticipate and monitor dynamically changing priorities</li>
 <li>Provide feedback and shared learning for continuous improvement</li>
 <li>Assist the teams with reviewing and ensuring that SOP, Job Aids, Flowcharts &amp; Ref Documents are up to date.</li>
 </ul>
 
 Minimum Qualifications
 <ul>
 <li>Experience in a finance function</li>
 <li>Associate degree (or equivalent work experience)</li>
 <li>Fluency in English is essential for this role.</li>
 <li>Ability to learn and comply with financial and legal guidelines and policies (budget and contract)</li>
 <li>Appreciation of / experience in compliance-driven environment</li>
 </ul>
 
 Additional Skills
 <ul>
 <li>Ability to handle complexity and utilize analytical skills, with attention to detail</li>
 <li>Ability to effectively prioritize and complete key tasks and deliverables</li>
 <li>Ability to both actively listen and effectively communicate</li>
 <li>Ability to work in global team environment and communicate effectively with both internal business partners of all levels &amp; disciplines as well as external partners and vendors.</li>
 </ul>
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
</div>


 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered.
 
  Path/Level:
 P1-P3
  Note: Roles are posted at the lowest level of a band, however, employees should search across all levels of the band to identify all opportunities. Employees hired on banded positions (ex: P1-P3, R1-R2, B1-B3, etc.) transfer at their current level, despite the level indicated on the job posting. For example, if a P2 candidate is selected for a P1-P3 banded position, the candidate will remain a P2 in the new role.
 
 At Eli Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 
 Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 This is a permanent position with a hybrid workplace where you will be expected to attend the office 50% of the time.
 
  Responsibilities
 Act as SME for the purchase to pay process for clinical trial investigator payments, including:
 
  Vendor creation and management
  PO creation and maintenance
  Identify, communicate, and resolve site issues
  Ensure country specific regulatory and data privacy requirements are incorporated into submission documents and any other documents/systems
  Understand and comply with procurements, legal and financial requirements and procedures
  Issue resolution related to rejected invoices
  Vendor follow up where invoices have not been received
  Identify, communicate, and resolve issues
  Liaise with 3rd party to maintain operational relationship
  Anticipate and monitor dynamically changing priorities
  Provide feedback and shared learning for continuous improvement
  Assist the teams with reviewing and ensuring that SOP, Job Aids, Flowcharts & Ref Documents are up to date.
 
 
  Minimum Qualifications
 
  Experience in a finance function
  Associate degree (or equivalent work experience)
  Fluency in English is essential for this role.
  Ability to learn and comply with financial and legal guidelines and policies (budget and contract)
  Appreciation of / experience in compliance-driven environment
 
 
  Additional Skills
 
  Ability to handle complexity and utilize analytical skills, with attention to detail
  Ability to effectively prioritize and complete key tasks and deliverables
  Ability to both actively listen and effectively communicate
  Ability to work in global team environment and communicate effectively with both internal business partners of all levels & disciplines as well as external partners and vendors.
 
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly


Associate / Sr. Associate- Trial Capabilities - Finance - Lilly

Associate / Sr. Associate- Trial Capabilities - Finance

You need a two-year degree or 2 years of relevant experience, proficiency in MS Office, strong communication, teamwork, organization, problem-solving skills, and ability to maintain confidentiality.

You will manage study budgets, track supplies and enrollment data, assist with study activities, maintain files, support inspections, and generate status and milestone reports.

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 Purpose:
 The Expert Specialist /Sr. Expert Specialist provides technical and project administrative support to the Clinical Development Trial Lead (CDTLs) to help enable on-time and on-budget delivery of key tasks during clinical trial execution. The Expert Specialist/ Sr. Expert Specialist supports trial, asset, and portfolio level tasks that may be assigned to a specific asset team(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU).
 
 Primary Responsibilities: 
 This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
 
 Clinical Trial Execution 
 <ul>
 <li>Assist in the management of study budgets including the setup of purchase orders and e-requisitions</li>
 <li>Order, track, and ship study supplies, tools, and/or instruments</li>
 <li>Track and report Regional/Global enrollment data for ongoing clinical studies</li>
 <li>Perform routine study activities per policies/procedures (e.g. Study closeout)</li>
 <li>Participate in shared learning forums</li>
 <li>May assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.)</li>
 </ul>
 
 Clinical Trial/Submission Documentation 
 <ul>
 <li>Support and partner with CDTLs and Management to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexing</li>
 <li>Support backroom for regulatory and mock inspections</li>
 <li>Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI)</li>
 </ul>
 <ul>
 <li>Establish, maintain, and use appropriate team information repositories (e.g. study collaboration site; eTMF) and maintain project team rosters.</li>
 <li>Support filing and archiving processes</li>
 </ul>
 
 Clinical Trial Systems Management
 <ul>
 <li>Accurately input study timelines and other trial level required fields into clinical trial database, monitors and updates fields as study timelines or other information changes and troubleshoots illogical data.</li>
 <li>Assist in producing and distributing project status reports</li>
 <li>Coordinate with CDTLs and Management to generate regional-level, trial-level and compound-level milestone and budget reports, enrolment reports, and other reports as needed.</li>
 </ul>
 
 Minimum Qualification Requirements:
 <ul>
 <li>Two-year degree or 2 years administrative or technical experience</li>
 <li>Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)</li>
 </ul>
 
 Highly Desired Skills:
 <ul>
 <li>Strong communication skills; able to communicate clearly and succinctly with team members and leadership</li>
 <li>Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills</li>
 <li>Strong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solving</li>
 <li>Ability to maintain confidentiality</li>
 </ul>
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
</div>


 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
  Purpose:
 The Expert Specialist /Sr. Expert Specialist provides technical and project administrative support to the Clinical Development Trial Lead (CDTLs) to help enable on-time and on-budget delivery of key tasks during clinical trial execution. The Expert Specialist/ Sr. Expert Specialist supports trial, asset, and portfolio level tasks that may be assigned to a specific asset team(s) or centrally across a Therapeutic Area (TA)/Business Unit (BU).
 
  Primary Responsibilities: 
 This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
 
  Clinical Trial Execution 
 
  Assist in the management of study budgets including the setup of purchase orders and e-requisitions
  Order, track, and ship study supplies, tools, and/or instruments
  Track and report Regional/Global enrollment data for ongoing clinical studies
  Perform routine study activities per policies/procedures (e.g. Study closeout)
  Participate in shared learning forums
  May assist with other appropriate trial level activities as needed (i.e. coordination of regional and trial project-related meetings, structure of newsletters, uploading minutes to the study collaboration site(s) or eTMFs as appropriate, etc.)
 
 
 Clinical Trial/Submission Documentation 
 
  Support and partner with CDTLs and Management to oversee maintenance and inspection readiness of study files (e.g. eTMF, study collaboration sites, etc.) including quality reviews (routine and pre-inspection), associated updates, and indexing
  Support backroom for regulatory and mock inspections
  Support collection and review of key information to support submission activities (i.e. collecting and verifying accurate information for financial disclosures/1572 and OSI)
 
 
  Establish, maintain, and use appropriate team information repositories (e.g. study collaboration site; eTMF) and maintain project team rosters.
  Support filing and archiving processes
 
 
  Clinical Trial Systems Management
 
  Accurately input study timelines and other trial level required fields into clinical trial database, monitors and updates fields as study timelines or other information changes and troubleshoots illogical data.
  Assist in producing and distributing project status reports
  Coordinate with CDTLs and Management to generate regional-level, trial-level and compound-level milestone and budget reports, enrolment reports, and other reports as needed.
 
 
  Minimum Qualification Requirements:
 
  Two-year degree or 2 years administrative or technical experience
  Computer proficiency and experience using a variety of software packages (e.g., Microsoft Word, Excel, Power Point, Project)
 
 
  Highly Desired Skills:
 
  Strong communication skills; able to communicate clearly and succinctly with team members and leadership
  Demonstrated ability to work effectively cross-culturally as well as across regions/geographies with strong customer service skills
  Strong teamwork and interpersonal skills including demonstrated ability to flex to changing business needs, attention to detail, strong self-management, organizational skills, and problem solving
  Ability to maintain confidentiality
 
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly


Expert Specialist /Sr. Expert Specialist, Clinical Development - Lilly

Expert Specialist /Sr. Expert Specialist, Clinical Development

You need a relevant bachelor’s degree, 2-3 years in labs or pharma, quality system knowledge, leadership skills, and familiarity with regulations. Advanced degree and global experience preferred.

You will manage compliance, quality systems, and audits; solve quality issues; consult on policies; oversee training; and support regulatory activities for laboratory and diagnostic services.

Research & Development

<div>
 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our
 work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age &amp; Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
 Organization Overview:
 The Medical Quality Organization (MQO) is actively seeking a Research and Clinical Laboratory Quality Representative. This individual will be tasked with upholding data integrity and compliance across a diverse array of laboratory environments, including discovery research, clinical laboratories, and clinical trials. The role involves ensuring adherence to quality systems, driving improvements, and fostering cross-functional collaboration with a variety of business partners.
 Furthermore, the MQO Research and Clinical Laboratory Quality Representative support the portfolio, and clinical diagnostic laboratory deliverables. This will involve harnessing Data-Driven Quality initiatives, cultivating deeper quality and technical expertise, and integrating quality into innovation. MQO seeks individuals with learning high learning agility, and adaptability to support and manage the ever-evolving regulatory landscape. This position offers a unique opportunity to lead, learn, and make a significant impact in the field of medical quality assurance.
 Responsibilities:
 <ul>
 <li>Understands Quality Systems (SEQS and DRQS): Procedures, Tools, Resources and how these are applied to business processes.</li>
 <li>Understands quality principles.</li>
 <li>Monitors and manages compliance, compliance issues, and understand appropriate escalation as necessary.</li>
 <li>Manages and implement business work via the Quality Management System: Notification to Management, Deviations, Root Cause Analysis, Change Control, etc.</li>
 <li>Solves problems related to quality issues using good judgement-based decision-making principles.</li>
 <li>Manages business focused expectations.</li>
 <li>Establishes experiences working within a global capacity.</li>
 <li>Ensures compliance with Quality Systems, internal guidelines, and external regulations.</li>
 <li>Consults with business partners for strategic and practical application of policies and procedures.</li>
 <li>Demonstrates ability to negotiation, influence, and problem-solving behaviors.</li>
 <li>Demonstrates inclusive, team-focused behavior.</li>
 <li>Demonstrates good verbal and written communication in English.</li>
 <li>Demonstrates good project management, prioritization, and evaluation of critical from non-critical issues.</li>
 <li>Demonstrates ability to identify root causes, manage difficult business/quality.</li>
 <li>Enables execution of local, regional, and global regulatory requirements for laboratory and diagnostic.</li>
 <li>Influences direction of quality decisions, partners with cross-functional teams and provides technical and regulatory considerations.</li>
 <li>Implement the Quality Plans as appropriate for the relevant systems.</li>
 <li>Consults and facilitates audits and management of associated audit observations for the business and related TPOs.</li>
 <li>Evaluates business metrics for trends, identifies gaps, areas of weakness.</li>
 <li>Drives simplification, shares key learnings, seeks process improvements, and replicates best practices; Partners with business process owners; Utilizes risk-based approaches.</li>
 <li>Review, edits, manages and approves business documents.</li>
 <li>Handles sensitive information with confidentiality.</li>
 <li>Provides periodic Quality updates with business leadership.</li>
 <li>Supports projects as needed.</li>
 <li>Consults with other functional representatives, as necessary.</li>
 <li>Manages the recruitment, development, retention of a highly capable and diverse team.</li>
 <li>Ensures assignment of relevant training, completion of work expectations, MQO competencies and assignment of coaches as needed.</li>
 <li>Understands core functional business process.</li>
 <li>Understands in depth Laboratory systems, Laboratory Data requirements, Data integrity.</li>
 <li>Understand working with Third Party Organizations related to services including but to limited to: Clinical Laboratory and Diagnostics, such as imaging, ECGs and connected device requirements.</li>
 <li>Manages global regulatory inspection activities, including continuous inspection readiness and management of regulatory responses/ Corrective Actions/ Preventative actions.</li>
 <li>Utilizes and manage quality metrics for process improvement initiatives.</li>
 <li>Exhibits expertise in LIS management, validation, archiving, audit train expectations, and regulatory requirements.</li>
 <li>Demonstrates experience in CLIA, GLP, or other Research related laboratories.</li>
 <li>Understands Clinical and non-clinical Drug Development and GxP regulations, guidelines, and standards.</li>
 <li>Understands Third-Party Management, TPO On-boarding, Oversight and Quality expectations.</li>
 <li>Consults Information Technology and associate IT Quality representatives as necessary</li>
 <li>Consults and supports implementation of new process, advises on training requirements and quality content for business processes.</li>
 <li>Consults in assessment of risk, audit planning and quality plans.</li>
 <li>Ensures appropriate controls are implemented and documented for business or regulatory requirements.</li>
 </ul>
 Basic Requirements:
 <ul>
 <li>Bachelor’s degree in Clinical Laboratory Sciences/ Medical Technology, life sciences, medically related field or equivalent work experience.</li>
 <li>Minimum 2-3 years of experience in a Clinical Laboratory, Pharmaceutical Research and/or Quality.</li>
 </ul>
 
 Additional Skills/Preferences:
 <ul>
 <li>Direct experience within Quality and/or demonstrated understanding and application of quality management systems</li>
 <li>Advanced degree in a scientific field, statistics, or data science.</li>
 <li>Supervisory experience</li>
 <li>Experience working in a global environment</li>
 <li>Proven mastery of data integrity principles in drug development and clinical research</li>
 <li>Demonstrated competency in engaging cross-functional team members to resolve issues while balancing timelines, various perspectives, and speaking up/leading when the destination is unclear.</li>
 <li>Strong leadership and self-management skills</li>
 <li>Strong verbal and written communication skills</li>
 <li>Knowledge of CLIA, GCP guidelines, GxPs, and regulations within the area of responsibility</li>
 <li>Demonstrated problem solving and critical thinking skills</li>
 </ul>
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly
</div>


 At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
 
 At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our
 work, and we put people first. We’re looking for people who are determined to make life better for patients around the world.
 Eli Lilly Cork is made up of a talented diverse team of over 1,800 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
 Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
 Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
 Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
 
  Organization Overview:
 The Medical Quality Organization (MQO) is actively seeking a Research and Clinical Laboratory Quality Representative. This individual will be tasked with upholding data integrity and compliance across a diverse array of laboratory environments, including discovery research, clinical laboratories, and clinical trials. The role involves ensuring adherence to quality systems, driving improvements, and fostering cross-functional collaboration with a variety of business partners.
 Furthermore, the MQO Research and Clinical Laboratory Quality Representative support the portfolio, and clinical diagnostic laboratory deliverables. This will involve harnessing Data-Driven Quality initiatives, cultivating deeper quality and technical expertise, and integrating quality into innovation. MQO seeks individuals with learning high learning agility, and adaptability to support and manage the ever-evolving regulatory landscape. This position offers a unique opportunity to lead, learn, and make a significant impact in the field of medical quality assurance.
  Responsibilities:
 
  Understands Quality Systems (SEQS and DRQS): Procedures, Tools, Resources and how these are applied to business processes.
  Understands quality principles.
  Monitors and manages compliance, compliance issues, and understand appropriate escalation as necessary.
  Manages and implement business work via the Quality Management System: Notification to Management, Deviations, Root Cause Analysis, Change Control, etc.
  Solves problems related to quality issues using good judgement-based decision-making principles.
  Manages business focused expectations.
  Establishes experiences working within a global capacity.
  Ensures compliance with Quality Systems, internal guidelines, and external regulations.
  Consults with business partners for strategic and practical application of policies and procedures.
  Demonstrates ability to negotiation, influence, and problem-solving behaviors.
  Demonstrates inclusive, team-focused behavior.
  Demonstrates good verbal and written communication in English.
  Demonstrates good project management, prioritization, and evaluation of critical from non-critical issues.
  Demonstrates ability to identify root causes, manage difficult business/quality.
  Enables execution of local, regional, and global regulatory requirements for laboratory and diagnostic.
  Influences direction of quality decisions, partners with cross-functional teams and provides technical and regulatory considerations.
  Implement the Quality Plans as appropriate for the relevant systems.
  Consults and facilitates audits and management of associated audit observations for the business and related TPOs.
  Evaluates business metrics for trends, identifies gaps, areas of weakness.
  Drives simplification, shares key learnings, seeks process improvements, and replicates best practices; Partners with business process owners; Utilizes risk-based approaches.
  Review, edits, manages and approves business documents.
  Handles sensitive information with confidentiality.
  Provides periodic Quality updates with business leadership.
  Supports projects as needed.
  Consults with other functional representatives, as necessary.
  Manages the recruitment, development, retention of a highly capable and diverse team.
  Ensures assignment of relevant training, completion of work expectations, MQO competencies and assignment of coaches as needed.
  Understands core functional business process.
  Understands in depth Laboratory systems, Laboratory Data requirements, Data integrity.
  Understand working with Third Party Organizations related to services including but to limited to: Clinical Laboratory and Diagnostics, such as imaging, ECGs and connected device requirements.
  Manages global regulatory inspection activities, including continuous inspection readiness and management of regulatory responses/ Corrective Actions/ Preventative actions.
  Utilizes and manage quality metrics for process improvement initiatives.
  Exhibits expertise in LIS management, validation, archiving, audit train expectations, and regulatory requirements.
  Demonstrates experience in CLIA, GLP, or other Research related laboratories.
  Understands Clinical and non-clinical Drug Development and GxP regulations, guidelines, and standards.
  Understands Third-Party Management, TPO On-boarding, Oversight and Quality expectations.
  Consults Information Technology and associate IT Quality representatives as necessary
  Consults and supports implementation of new process, advises on training requirements and quality content for business processes.
  Consults in assessment of risk, audit planning and quality plans.
  Ensures appropriate controls are implemented and documented for business or regulatory requirements.
 
  Basic Requirements:
 
  Bachelor’s degree in Clinical Laboratory Sciences/ Medical Technology, life sciences, medically related field or equivalent work experience.
  Minimum 2-3 years of experience in a Clinical Laboratory, Pharmaceutical Research and/or Quality.
 
 
  Additional Skills/Preferences:
 
  Direct experience within Quality and/or demonstrated understanding and application of quality management systems
  Advanced degree in a scientific field, statistics, or data science.
  Supervisory experience
  Experience working in a global environment
  Proven mastery of data integrity principles in drug development and clinical research
  Demonstrated competency in engaging cross-functional team members to resolve issues while balancing timelines, various perspectives, and speaking up/leading when the destination is unclear.
  Strong leadership and self-management skills
  Strong verbal and written communication skills
  Knowledge of CLIA, GCP guidelines, GxPs, and regulations within the area of responsibility
  Demonstrated problem solving and critical thinking skills
 
 
 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
 
 Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
 
 #WeAreLilly


Lilly

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