Senior Director, Compliance & Strategy — Regulatory Excellence

Bristol-Myers Squibb Co; Harvard (MA); On-site; USD 225,000 - 273,000; Full time

Job summary

Bristol Myers Squibb is seeking a Sr. Director, Compliance & Strategy, MQSA to lead enterprise aseptic and microbial control programs, regulatory intelligence, and global compliance readiness across the manufacturing network.

You will shape strategy, engage with health authorities, and drive harmonization across sites, ensuring adherence to evolving global regulations and quality standards.

Qualifications

• Bachelor's degree as listed in Education.
• 15+ years of progressive pharmaceutical industry experience in microbiology, sterility assurance, contamination control, or aseptic processing.
• 8–10 years in senior leadership roles with enterprise-level accountability for manufacturing, technology, quality, compliance, or regulatory strategy.
• Deep experience across multiple manufacturing modalities including small molecule, biologics, cell therapy, or gene therapy.
• Proven expertise in global regulatory frameworks (FDA, EU, ICH, USP, PIC/S).
• Track record of leading enterprise-wide harmonization and change management programs.

Responsibilities

• Define and govern enterprise aseptic and microbial regulatory intelligence and surveillance programs.
• Drive engagement strategy with health authorities and industry bodies to shape standards.
• Oversee regulatory inspections readiness and provide science-based responses.
• Define and drive CMO/CDMO governance for aseptic practices and microbial control obligations.
• Lead training, capability development, and competency programs across manufacturing sites.

Education

Bachelor's degree in Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, or related scientific discipline

Job description

Bristol Myers Squibb is seeking a Sr. Director, Compliance & Strategy, MQSA to lead enterprise aseptic and microbial control programs, regulatory intelligence, and global compliance readiness across the manufacturing network.

You will shape strategy, engage with health authorities, and drive harmonization across sites, ensuring adherence to evolving global regulations and quality standards.