Associate Director, Aseptic Facility and Utility Design
$173.28k - $209.98kBristol Myers Squibb
Associate Director role overseeing aseptic facility and utility design governance at a biopharmaceutical manufacturer. Responsible for risk assessments, quality impact governance, design standards development, and regulatory inspection readiness across global manufacturing sites.
Responsibilities
- Review and approve global risk assessments and quality impact assessments for contamination events and microbial control failures
- Author high-complexity technical assessments supporting regulatory submissions and cross-site alignment
- Serve as global quality subject matter expert for aseptic facility and utility design approvals
- Define enterprise quality standards for cleanrooms, barrier systems, and critical utilities aligned with regulatory guidance
- Provide design-phase oversight for facility and utility changes to ensure contamination risks are identified and controlled
Requirements
- B.S. in Microbiology, Pharmaceutical Sciences, Biology, Biochemistry, or related discipline
- 10+ years sterility assurance, aseptic manufacturing, microbiology, or pharmaceutical quality experience
- 4+ years in leadership or enterprise-level quality role
- Expert knowledge of FDA Aseptic Processing Guidance, EU GMP Annex 1, USP and ISO standards
- Demonstrated regulatory inspection defense experience with FDA and EMA
- Proficiency in risk assessment methodologies and contamination control strategy development
- Experience with sterilization validation and single-use system qualification
Vacancy posted 17 days ago
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