Executive Director, Microbiology Quality Sterility Assurance

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