Associate Director, Aseptic Facility and Utility Design

$173.28k - $209.98k

Bristol Myers Squibb

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

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Vacancy posted 5 days ago

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