Executive Director, Microbiology Quality Sterility Assurance
$260.86k - $316.1kBristol Myers Squibb
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 21 days ago
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