Sr. Director, Compliance & Strategy, MQSA

Role: Senior Director leading enterprise contamination control and aseptic processing governance for Bristol Myers Squibb, focusing on microbial risk management across all manufacturing modalities. Responsibilities include developing and maintaining global standards, policies, and frameworks for sterile, aseptic, and microbial control; overseeing regulatory intelligence and compliance strategies; supporting inspection readiness; and governing external CMO/CDMO aseptic practices. The role involves defining strategic roadmaps, driving innovation adoption, and ensuring site-level implementation of enterprise standards. It also encompasses overseeing training, capability development, and external industry engagement to shape best practices. Qualifications: Bachelor's degree in Microbiology, Biology, or related fields; over 15 years of progressive pharmaceutical microbiology, sterility assurance, or contamination control experience, including 8-10 years in senior leadership roles with enterprise responsibility; extensive expertise across multiple modalities such as biologics, small molecules, or cell/gene therapy; deep knowledge of global regulatory frameworks (FDA, EMA, ICH, USP); proven experience with regulatory inspections and CMO oversight. Preferred qualifications include an M.S. or Ph.D. in Microbiology or related discipline. The role requires strong strategic, scientific, and stakeholder engagement skills, with proven ability to influence globally dispersed teams and external partners. Work setup is hybrid, based in Devens, MA, with responsibilities spanning regulatory, quality, manufacturing, and external engagement in aseptic processing and microbial control.