Associate Director, MQSA Regulatory Intelligence and Standards
$175.31k - $212.44kBristol Myers Squibb
Bristol Myers Squibb seeks an Associate Director to lead regulatory intelligence, compliance, and standards oversight for aseptic processing and microbial quality across global manufacturing operations. The role manages enterprise governance, Health Authority engagement, inspection readiness, and cross-site capability development within a complex manufacturing network.
Responsibilities
- Execute enterprise regulatory intelligence program; monitor and assess evolving global regulations and Health Authority expectations for aseptic and microbial processes
- Own global procedural documents, policies, and governance standards; conduct compliance gap assessments across manufacturing environments
- Lead inspection readiness activities; serve as primary subject matter expert during Health Authority inspections and regulatory engagements
- Drive cross-site learning initiatives and aseptic training program development to ensure consistent contamination control practices
- Establish CCS/SA standards in CMO/CDMO quality agreements and coordinate external manufacturing partner compliance assessments
Requirements
- Deep expertise in FDA 21 CFR Parts 210/211/600, EU GMP Annex 1, ICH Q9/Q10, and relevant USP/PIC/S standards
- Proven experience in regulatory intelligence, compliance gap assessment, and Health Authority interaction in pharmaceutical manufacturing
- Strong background in aseptic processing, contamination control, and microbial quality assurance
- Demonstrated ability to translate regulatory requirements into actionable enterprise procedures and governance documentation
- Experience managing cross-functional teams and driving operational change across multiple manufacturing sites
- Technical knowledge of inspection readiness, regulatory response, and compliance documentation
Vacancy posted 18 days ago
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