Senior Manager Cell Therapy QA External Drug Product Quality Specialist
vor 1 Woche
We are seeking a highly skilled Senior Manager to join our Cell Therapy QA team. As a key member of our organization, you will be responsible for overseeing 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 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 act as a central point of contact for all Quality-related topics in relation to 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 dedicated to transforming patients' lives through science. Our mission is to define and deliver the world's most trusted cell therapy experience. We are committed to creating a diverse and inclusive work environment that promotes innovation, collaboration, and excellence.
We are an equal opportunities employer and welcome applications from diverse candidates. If you require reasonable accommodations or adjustments in completing this application, please contact us. We are committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments, and ongoing support in their roles.
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Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleWe 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 ResponsibilitiesOversee and...
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Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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Boudry, Schweiz Bristol Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
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