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Sr. Director, Compliance & Strategy, MQSA

$224.9k - $272.53k

Bristol 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 18 days ago
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