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Senior Manager Cell Therapy Quality Assurance External Drug Product
vor 1 Monat
Transforming Patients' Lives through Science
Bristol Myers Squibb is a leading company in the development of innovative treatments for various diseases. We are seeking a highly skilled and experienced Senior Manager to join our Cell Therapy team. This individual will be responsible for overseeing the quality assurance of external drug products, ensuring compliance with regulatory requirements and maintaining the highest standards of quality.
Key Responsibilities:
- Oversee the quality assurance of external drug products, including CAR-T products
- Partner with QA VPT Leads to provide quality oversight of Contract Manufacturing Organizations (CMOs)
- Collaborate with internal functions and stakeholders to ensure seamless manufacturing operations
- Develop and implement quality strategies to drive efficiency and process improvements
- Represent BMS in internal inspections and audits, ensuring compliance with regulatory requirements
- Support technology transfer from internal sites to CMOs and participate in key projects related to manufacturing process changes
- Ensure flawless execution of transfer, qualification, and validation of manufacturing processes, devices, and analytical methods
Requirements:
- Master's degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy, or closely related areas
- Minimum 7 years of EU GMP regulated industry experience, with at least 5 years in quality assurance and/or compliance
- Strong knowledge of relevant regulations and guidance for ATMP
- Expertise in transfer projects and process changes, including technology transfer and analytical method transfer
- 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 and communicate effectively with external partners
- Ability to prioritize and successfully manage complex and competing tasks and projects
- Travel: up to 20% of the time
About Bristol Myers Squibb
Bristol Myers Squibb is a company that values diversity, inclusion, and innovation. We are committed to transforming patients' lives through science and are dedicated to creating a workplace that is inclusive and supportive of all employees. We believe in the importance of work-life balance and offer a range of benefits and programs to support our employees' well-being. If you are a motivated and experienced individual who is passionate about quality assurance and compliance, we encourage you to apply for this exciting opportunity.
