Cell Therapy QA Lead
vor 1 Monat
Bristol Myers Squibb is a leading pharmaceutical company that is transforming the lives of patients through science. We are seeking a highly skilled Cell Therapy QA Lead to join our team and contribute to our mission of delivering innovative treatments to patients worldwide.
About the RoleThe Cell Therapy QA Lead 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. This role will require strong knowledge of relevant regulations and guidance for ATMP, as well as expertise in Transfer Projects (e.g. Tech Transfer, Analytical Method Transfer). The successful candidate will have a Master's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas, and a minimum of 10 years EU GMP regulated industry experience with a minimum of 5 years' experience in quality assurance and/or 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.
Bristol Myers Squibb offers a dynamic and inclusive work environment that fosters innovation, collaboration, and growth. As a Cell Therapy QA Lead, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality treatments to patients. We offer a competitive salary and benefits package, as well as opportunities for professional development and advancement.
How to ApplyIf you are a motivated and experienced quality professional looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information]. We look forward to hearing from you
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