Sr. Director, Compliance & Strategy, MQSA
$224.9k - $272.53kBristol Myers Squibb
Senior Director role overseeing enterprise-wide aseptic processing, contamination control, and microbial quality frameworks across Bristol Myers Squibb's global manufacturing network. Responsible for governance, regulatory strategy, compliance alignment, and technical leadership spanning sterile and non-sterile operations.
Responsibilities
- Own and maintain enterprise governance framework for contamination control, sterile practices, and microbial quality standards across all modalities
- Define and drive aseptic and microbial control roadmap with long-range strategic objectives, KPIs, and performance monitoring
- Lead regulatory intelligence surveillance programs and drive compliance alignment for evolving aseptic processing requirements
- Oversee CMO/CDMO quality agreements and compliance assessments for external manufacturing partners
- Develop and maintain global aseptic training programs, qualification frameworks, and competency assurance across manufacturing sites
Requirements
- Bachelor's degree in microbiology, biology, biochemistry, pharmaceutical sciences, or chemical engineering
- 15+ years progressive pharmaceutical industry experience in microbiology, sterility assurance, or aseptic processing
- 8–10 years senior leadership with enterprise accountability for manufacturing, quality, compliance, or regulatory strategy
- Deep experience across multiple manufacturing modalities including small molecule and biologics
- Expertise in contamination control requirements, risk methodologies, and regulatory expectations
- Knowledge of global aseptic and microbial control regulations and guidance documents
Vacancy posted 19 days ago
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