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Senior Manager QA

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Amgen

22d ago

  • Job
    Full-time
    Senior & Expert Level
  • Engineering
  • Hyderabad, +1

AI generated summary

  • You need a Master's (8-10 yrs), Bachelor's (10-14 yrs), or Diploma (14-18 yrs) in a relevant field, quality certifications, audit experience, strong organization, adaptability, teamwork, and problem-solving skills.
  • You will oversee QMS development, conduct audits, drive improvements, ensure compliance, train staff, analyze data, maintain documentation, and lead a quality-focused team.

Requirements

  • Master’s degree and 8 to 10 years of relevant field (e.g., Quality Management, Engineering, Business Administration experience OR
  • Bachelor’s degree and 10 to 14 years of relevant field (e.g., Quality Management, Engineering, Business Administration experience OR
  • Diploma and 14 to 18 years of relevant field (e.g., Quality Management, Engineering, Business Administration experience
  • Certifications in quality management (e.g., ISO 9001, Six Sigma) are highly desirable.
  • Proven experience in conducting audits and managing QMS-related projects.
  • Strong organizational skills, with the ability to prioritize tasks and manage multiple projects simultaneously.
  • Excellent adaptability, with the ability to quickly grasp new concepts and react to changes in a rapidly evolving environment.
  • Strong teamwork skills, with the ability to work well with others and contribute to a positive team environment.
  • Strong problem-solving skills, with the ability to analyze and resolve issues related to documentation and processes.
  • Customer-focused mindset, with a commitment to understanding and meeting the needs of internal and external collaborators.

Responsibilities

  • QMS Oversight: Lead the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with industry standards and best practices.
  • Audit Management: Plan, conduct, and oversee internal and external audits to ensure compliance with QMS requirements and identify areas for improvement.
  • Continuous Improvement: Drive continuous improvement initiatives across the organization, applying quality management tools and methodologies such as Six Sigma and Lean.
  • Regulatory Compliance: Ensure compliance with relevant quality standards (e.g., ISO 9001) and regulatory requirements.
  • Training and Development: Develop and deliver training programs to ensure that all employees are knowledgeable about QMS processes and best practices.
  • Collaborator Engagement: Collaborate with internal and external collaborators to address quality-related issues and ensure customer satisfaction.
  • Data Analysis: Analyze quality data to identify trends, root causes, and opportunities for improvement.
  • Documentation: Maintain accurate and up-to-date QMS documentation, including policies, procedures, and records.
  • Team Leadership: Lead and mentor a team of quality professionals, fostering a culture of excellence and continuous improvement.

FAQs

What is the primary mission of Amgen?

Amgen's primary mission is to serve patients living with serious illnesses by researching, manufacturing, and delivering innovative medicines.

What are the key responsibilities of the Senior Manager QA?

The key responsibilities include overseeing the Quality Management System (QMS), conducting audits, driving continuous improvement initiatives, ensuring regulatory compliance, delivering training, collaborating with stakeholders, analyzing quality data, maintaining QMS documentation, and leading a team of quality professionals.

What qualifications are required for the Senior Manager QA position?

Candidates must have a Master’s degree with 8 to 10 years of relevant experience, a Bachelor’s degree with 10 to 14 years of relevant experience, or a Diploma with 14 to 18 years of relevant experience. Certifications in quality management (e.g., ISO 9001, Six Sigma) are highly desirable.

What skills are emphasized for the Senior Manager QA role?

The role emphasizes strong organizational and problem-solving skills, adaptability, teamwork, a customer-focused mindset, and the ability to analyze and resolve documentation and process-related issues.

Is experience in conducting audits a requirement for this position?

Yes, proven experience in conducting audits and managing QMS-related projects is required for the Senior Manager QA position.

How does Amgen support employee professional and personal growth?

Amgen supports employee growth through competitive benefits, a collaborative culture, and comprehensive Total Rewards Plans that align with local industry standards.

What qualities does Amgen seek in its workforce?

Amgen seeks a diverse, ethical, committed, and highly accomplished workforce that respects each other and embodies the Amgen values in advancing science to serve patients.

Are there opportunities for training and development as part of this role?

Yes, the Senior Manager QA will develop and deliver training programs to ensure that all employees are knowledgeable about QMS processes and best practices.

What type of work environment can one expect at Amgen?

Amgen offers an award-winning culture that is collaborative, innovative, and science-based, focused on teamwork and customer satisfaction.

Does Amgen have an equal opportunity employment policy?

Yes, Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

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Amgen

#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.