Senior Manager Cell Therapy QA External Drug Product Quality Specialist
vor 1 Monat
Job Summary
We are seeking a highly skilled Senior Manager Cell Therapy QA External Drug Product Quality to join our team at Bristol Myers Squibb. This role will be responsible for overseeing operational tasks performed by external partners involved in Cell Therapy (CAR-T) manufacturing.
Key Responsibilities
- Oversee and control operational tasks performed by external partners involved in Cell Therapy (CAR-T) manufacturing.
- Independently execute internal operational Quality tasks related to manufacturing steps for CAR T products in Europe.
- Partner with QA VPT Leads to provide Quality oversight of Contract Manufacturing Organizations (CMOs).
- Partner with VPT teams and acting as central point of contact for all Quality related topics in relation to the assigned tasks for internal and external stakeholders.
- Take lead in projects, escalations or other initiatives.
Requirements
- Master's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
- Min. 7 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 and process changes (e.g. Tech Transfer, Analytical Method Transfer, Ramp up projects).
- Fluent in English, and preferably local language of CMO.
- Strong organizational skills, including ability to follow assignments through to completion.
- Independent decision-making capability and ability to think conceptually and understand impact of decisions.
- Excellent verbal and written communication skills.
- Ability to work in cross functional teams.
- Proficient in communication with external partners to build a trustful and professional relationship.
- Ability to prioritize and successfully manage complex and competing tasks and projects.
What We Offer
Bristol Myers Squibb is a diverse and inclusive company that offers a range of benefits and opportunities for growth and development. We are committed to creating a work environment that is supportive, collaborative, and inclusive.
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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