Senior Quality Assurance Manager Cell Therapy External Drug Product Quality
Vor 6 Tagen
Job Summary
Bristol Myers Squibb is seeking a highly skilled Quality Assurance Manager to join our Cell Therapy team. As a Quality Assurance Manager, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for commercial and clinical CAR T products in Europe.
Key Responsibilities
- Provide Quality oversight of CMOs performing critical manufacturing steps for commercial and clinical CAR T products in Europe.
- Take responsibility of QA lead function in cross functional VPT team and acting as central point of contact for all Quality related topics in relation to the assigned CMO for internal and external stakeholders.
- Represent the organization in internal management reviews and take accountability for CMO related metrics, issues, and projects.
- Responsible for Quality Review meetings with internal and external management.
- Act as Quality lead in Technology Transfer from internal sites to CMO and/or key projects related to manufacturing process like expansions, ramp up or major process changes.
Requirements
- Master's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
- Min. 10 years EU GMP regulated industry experience with a minimum of 5 years' experience in quality assurance and/or compliance.
- Strong knowledge of relevant regulations and guidance for ATMP.
- Expertise in Transfer Projects (e.g. Tech Transfer, Analytical Method Transfer)
What We Offer
Bristol Myers Squibb offers a dynamic and inclusive work environment, competitive compensation and benefits package, and opportunities for professional growth and development.
How to Apply
If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your application, including your resume and cover letter, to our website.
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