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Quality Compliance Senior Manager

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Amgen

11d ago

  • Job
    Full-time
    Senior & Expert Level
  • Healthcare
  • Cambridge

AI generated summary

  • You should have experience in quality management in pharma/biotech, expertise in QMS, knowledge of clinical R&D, GCP oversight, strong communication skills, and a degree. Leadership experience is a plus.
  • You will provide GCP expertise, conduct risk-based audits, manage quality events, oversee risk assessments, support vendor qualifications, analyze quality data trends, and coordinate data collection technologies.

Requirements

  • Experience in Quality Management, Quality Assurance, or other relevant risk-based quality practices in the pharmaceutical/biotech industry
  • Expertise in Quality Management Systems (QMS), including electronic systems like Veeva or TrackWise
  • Strong knowledge of Clinical R&D, global regulations and regulatory submissions
  • Quality Oversight of Clinical Trials, including protocol development, execution and submissions
  • Experience within GCP, including conducting audits and managing inspections
  • Excellent communication, active listening, strong analytical and decision-making skills
  • Leadership or mentoring experience is considered a plus
  • Degree educated

Responsibilities

  • Serve as a Good Clinical Practices (GCP) Subject Matter Expert, providing independent quality guidance for clinical trials
  • Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits
  • Manage quality events and regulatory inspections, and advise on responses, including root cause analysis and CAPA plans
  • Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) to identify and mitigate trial risk
  • Support monthly meetings with clinical program leaders to review quality and compliance risks, including deviations, trends, filing timelines, inspections, and cross-program risks
  • Conduct new vendor qualifications in a risk-based manner
  • Analyze data quality trends, address areas of weakness and gaps, implement and communicate key quality metrics
  • Coordinate and support key technologies for data collection and measurement (e.g., biomarker usage and imaging methods)

FAQs

What is the primary role of the Quality Compliance Senior Manager at Amgen?

The primary role is to provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in the clinical development program.

What are the key responsibilities of this role?

Key responsibilities include serving as a GCP Subject Matter Expert, conducting risk-based GCP audits, managing quality events and regulatory inspections, ensuring quality oversight for risk assessment, analyzing data quality trends, and coordinating key technologies for data collection.

What qualifications are required for this position?

Candidates should have experience in Quality Management or Quality Assurance in the pharmaceutical/biotech industry, expertise in Quality Management Systems (QMS), strong knowledge of Clinical R&D and global regulations, and experience within GCP, including audits and inspections.

Is leadership experience considered important for this role?

Yes, leadership or mentoring experience is considered a plus for this position.

Where is the position located?

The position offers the ability to work flexibly from home, with regular office work either from the Cambridge or Uxbridge next-generation workspace.

What kind of company culture does Amgen promote?

Amgen promotes a diverse and inclusive community where teammates are empowered to bring ideas to the table and act, valuing professional and personal growth and well-being.

What benefits does Amgen offer to employees?

Amgen offers a generous Total Rewards Plan that includes health, finance and wealth benefits, work/life balance, and career benefits along with vast opportunities for learning and movement within the global organization.

How does Amgen ensure equal opportunity in employment?

Amgen is an Equal Opportunity employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

What accommodations are available for individuals with disabilities during the hiring process?

Amgen ensures that individuals with disabilities are provided reasonable accommodations to participate in the job application or interview process and to perform essential job functions. They can request accommodations directly.

#WeareBiotech

Science & Healthcare
Industry
10,001+
Employees
1980
Founded Year

Mission & Purpose

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.