External Quality Assurance Specialist in Cell Therapy Manufacturing
Vor 7 Tagen
At Bristol Myers Squibb, we are committed to transforming patients' lives through science. As a Senior Manager in our External Drug Product Quality team, you will play a critical role in ensuring the quality of our cell therapy products.
Job SummaryWe are seeking an experienced External Quality Assurance Specialist to join our team. This is a challenging and rewarding role that requires strong leadership skills, attention to detail, and a passion for quality.
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 the 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.
- Masters degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy, or closely related areas.
- Minimum 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 trustful and professional relationships.
- Ability to prioritize and successfully manage complex and competing tasks and projects.
This position offers a competitive salary range of $120,000 - $160,000 per year, based on location and experience. In addition to the base salary, you will be eligible for bonus opportunities and a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
Work EnvironmentThis role requires up to 20% travel and may involve working in a fast-paced environment with multiple deadlines and priorities. You will be required to maintain confidentiality and handle sensitive information with discretion.
What We OfferBristol Myers Squibb is committed to creating a diverse and inclusive workplace where everyone has the opportunity to thrive. We offer a range of benefits and programs to support your physical and mental well-being, career development, and work-life balance.
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