Associate Director Cell Therapy QA External Drug Product Quality Expert
vor 1 Monat
Transforming Patients' Lives through Science
Bristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director to join our Cell Therapy QA External Drug Product Quality team.
About the Role
This is a unique opportunity to work in a cross-functional team, overseeing the quality of our commercial and clinical CAR T products in Europe. As a Quality Assurance Director, you will be responsible for providing quality oversight of Contract Manufacturing Organizations (CMOs) and ensuring that our products meet the highest standards of quality and regulatory compliance.
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, with opportunities for professional growth and development. We are committed to diversity, equity, and inclusion, and we strive to create a workplace where everyone feels valued and respected.
How to Apply
If you are a motivated and experienced professional looking for a new challenge, please submit your application, including your resume and a cover letter, to our website.
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