Manager, MSAT Investigations
Bristol Myers Squibb · Leiden, Netherlands
CMCFull-timeCompany career page
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Role summary
Bristol Myers Squibb seeks a Manager of Investigations for its Cell Therapy Manufacturing Facility in Leiden. The role involves leading complex root cause analyses, managing corrective and preventative actions, coordinating with cross-functional teams, and ensuring cGMP compliance and regulatory readiness.
What they're looking for
- Root cause analysis tools and CAPA identification experience required
- Bachelor's degree in science, engineering, biochemistry or related field plus 5+ years biopharmaceutical operations experience
- Proficient in cGMP regulations and multi-national biopharmaceutical/cell therapy compliance
- Excellent verbal and written communication with ability to influence at all organizational levels
- Cell therapy, biologics, or vaccine manufacturing experience desired
- Operational Excellence and Lean Manufacturing experience a plus
- Product complaints and APQR experience a plus
What you'll be doing
- Conduct and manage resolution of complex multi-functional root cause investigations as Lead Investigator
- Collaborate across Process Engineering, Manufacturing Operations, Quality Assurance, and Quality Control teams
- Manage investigation and CAPA progression to timely closure per established KPIs
- Present investigation findings to stakeholders and senior management
- Support regulatory inspections and maintain cGMP compliance and inspection readiness
Privacy & handoff
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