EU QP, Cell Therapy QA Manager – GMP/ATMP

Bristol-Myers Squibb Co; Leiden; À distance; EUR 110 000 - 150 000; Plein temps

Résumé du poste

Bristol Myers Squibb is seeking a Manager QA, EU QP Cell Therapy for Europe and Rest of World Markets. The role focuses on implementing the Quality Assurance function and ensuring product quality for ATMPs in the EU and beyond.

You will act as Qualified Person for investigational and commercial cell therapy products, ensuring compliance with EU GMP/GDP and engaging with cross-functional teams to drive timely batch disposition and regulatory adherence.

Qualifications

• MSc (or equivalent) in a technical or scientific discipline and eligible to act as Qualified Person.
• EU Qualified Person eligibility as described in EU regulations.
• Extensive quality assurance/control experience in biotechnology (≈6+ years).
• Experience with aseptic manufacturing and cell therapy products.
• Excellent communication, collaboration, and dispute-resolution skills in a team setting.
• Strong organizational, project management, and problem-solving abilities.
• Thorough knowledge of GMP/GDP requirements and global regulations.

Responsabilités

• Act as Qualified Person under BMS Netherlands Operations BV licenses and perform duties per conduct code.
• Fulfil QP duties per EU regulations and ATMP guidelines.
• Interpret international, regional, and local regulations and ensure GMP/GDP compliance across EU/EEA and RO World Markets.
• Verify QP certification of ATMPs and IMPs for import into the UK per MHRA guidelines.
• Develop knowledge of cell therapy processes and commercialization plans.
• Collaborate with QA, Supply Chain, and site/vendor oversight functions to ensure compliant batch disposition.
• Support inspections and implement corrective actions where needed.
• Maintain and improve quality risk assessments and release processes.

Connaissances

Quality assurance

Excellent communication

Organizational skills

Problem solving

Attention to detail

Regulatory knowledge

Team collaboration

Computer proficiency

Formation

MSc or equivalent in science/tech

EU Qualified Person eligibility

Description du poste

Bristol Myers Squibb is seeking a Manager QA, EU QP Cell Therapy for Europe and Rest of World Markets. The role focuses on implementing the Quality Assurance function and ensuring product quality for ATMPs in the EU and beyond.

You will act as Qualified Person for investigational and commercial cell therapy products, ensuring compliance with EU GMP/GDP and engaging with cross-functional teams to drive timely batch disposition and regulatory adherence.