Associate Director, Aseptic Facility and Utility Design

Bristol Myers Squibb seeks an Associate Director to oversee aseptic facility and utility design quality standards globally. The role combines risk governance, regulatory inspection readiness, and enterprise-level technical authority for contamination control across manufacturing sites and external partners.

Responsibilities

• Review and approve global risk assessments and quality impact assessments for contamination events and microbial control failures
• Lead authorship of complex Business Technical Assessments supporting regulatory submissions and cross-site technical alignment
• Serve as global quality subject matter expert for aseptic facility and utility design, reviewing design packages, URS, and DQ protocols
• Define and maintain enterprise-level quality standards for aseptic facility design aligned with EU GMP Annex 1, FDA guidance, and ISO 14644
• Provide technical oversight for facility and utility changes, ensuring contamination risks are identified and controlled at the design stage

Requirements

• Bachelor's degree in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related scientific discipline
• 10+ years progressive experience in sterility assurance, aseptic manufacturing, or pharmaceutical quality
• At least 4 years in a leadership or enterprise-level role
• Deep expertise in aseptic processing, environmental monitoring, contamination control, and microbial risk assessment
• Demonstrated experience authoring and defending technical positions during regulatory inspections
• Proven track record designing or overhauling APS/media fill programs or CCS frameworks at network or enterprise scale
• Expert knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1 (2022), USP <1116> , and ISO standards