Executive Director, Microbiology Quality Sterility Assurance

Bristol Myers Squibb · Princeton, NJ +4 more

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QualityFull-time$261k–$316kCompany career page

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Role summary

Bristol Myers Squibb seeks an Executive Director to lead global microbiology quality and sterility assurance across internal and external manufacturing sites. This strategic role establishes enterprise-wide contamination control governance, ensures regulatory compliance, and drives technical excellence in microbiological controls for pharmaceuticals, biopharmaceuticals, cell therapies, and radiopharmaceuticals.

What they're looking for

Deep expertise in sterility assurance, microbiological controls, and contamination control strategy
Extensive knowledge of EU GMP Annex 1, FDA, WHO, and global regulatory standards
Proven executive leadership experience in quality or manufacturing functions
Technical background in microbiological testing, terminal sterilization, or aseptic processes
Experience managing external partners, CMOs, and cross-functional stakeholder alignment
Strong business acumen with capital planning and investment decision-making experience

What you'll be doing

Define, own, and govern enterprise-wide Global Contamination Control Strategy as a living, risk-based framework
Lead microbiological oversight across pharmaceutical, biopharmaceutical, cell therapy, and radiopharmaceutical manufacturing operations
Serve as executive Single Point of Contact for sterility assurance and microbiology quality matters globally
Support CMO partners in establishing annual Contamination Control Strategies and conducting due diligence during onboarding
Lead or oversee complex microbiological investigations, CAPA development, and regulatory inspection engagement

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