Senior Quality Assurance Manager
vor 2 Monaten
We are seeking a highly skilled and experienced Senior Manager to join our Cell Therapy team at Bristol Myers Squibb. As a key member of our External Quality Assurance team, you will be responsible for overseeing the operational activities related to external partners involved in Cell Therapy 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
- 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
- Travel: This position requires up to 20% of travel
Bristol Myers Squibb is a leading biopharmaceutical company that is dedicated to transforming patients' lives through science. Our company is built on a foundation of innovation, urgency, accountability, inclusion, and integrity. We are committed to creating a diverse and inclusive work environment that promotes diversity in clinical trials and fosters a culture of collaboration and innovation.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, please direct your inquiries to.
We care about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
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Boudry District, Schweiz Bristol Myers Squibb VollzeitJob SummaryBristol 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...
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