Executive Director, QA Sterility Assurance

Role: Executive Director, QA Sterility Assurance, leading the contamination control strategy for Regeneron's biopharmaceutical manufacturing. Responsibilities include designing and improving microbiological environmental controls, overseeing aseptic processing and media fill programs, investigating microbial excursions, and ensuring compliance with evolving regulatory standards like EU Annex 1 and FDA Guidance. The role involves partnering with manufacturing, microbiology, engineering, and QA functions to translate contamination control strategies into operational practices, providing expert guidance on environmental monitoring, cleanroom classification, and aseptic techniques. Qualifications: Bachelor's degree in Microbiology, Molecular Biology, or related fields; 18+ years of microbiology and contamination control experience, including significant leadership in aseptic manufacturing. Expertise needed in GMP, low-bioburden manufacturing, environmental monitoring, media fills, and regulatory expectations. Preferred: experience with regulatory inspections and risk management tools like FMEA. The position is based in East Greenbush, NY, Monday-Friday, with responsibilities for representing microbiological standards to regulators and internal leadership, ensuring product sterility and patient safety.