Associate Director, MQSA Regulatory Intelligence and Standards

Role: Associate Director of MQSA Regulatory Intelligence and Standards, focusing on aseptic processing, contamination control, and microbial quality in biopharmaceutical manufacturing. Responsibilities include executing the enterprise regulatory surveillance program, assessing impact of global regulation changes, supporting regulatory engagements with health authorities during inspections, and maintaining compliance documentation. The role oversees governance of microbial quality standards, drives inspection readiness, and develops enterprise roadmaps for contamination control strategies. It also involves managing external partner standards, fostering cross-site learning, and industry benchmarking. Qualifications: B.S. in Microbiology, Pharmaceutical Sciences, Biology, or related field; minimum 14 years of experience in sterility assurance, contamination control, or aseptic processing within a regulated biopharma environment. Demonstrated expertise in engaging with FDA, EMA, and other regulators, with a track record of developing global quality standards and leading compliance teams. Preferred: M.S. degree. High-Value: Extensive microbiology and regulatory compliance expertise in biologics or sterile manufacturing, with leadership in microbiological risk management, GxP regulations, and industry collaborations. Work setup involves up to 10% travel; location is flexible within the U.S.