Site Sterility Lead, Associate Director - Dundalk

Job description

Job Description A fantastic opportunity has arisen for an Associate Director, Site Sterility Lead to join our expanding team at our company Dundalk. Our facility is dedicated to formulating and filling vaccine products that improve and transform lives globally. This position offers a high-impact opportunity to shape aseptic standards, mentor operations personnel, and influence the long-term success of sterile product manufacturing in a dynamic, multi-product environment. Your Key Responsibilities: You'll drive excellence in sterile manufacturing through expert coaching, oversight of cleanroom behaviors and contamination control, and strategic continuous improvement. Support sitewide sterility assurance initiatives, ensuring alignment with current regulatory standards including EU GMP Annex 1 (2023), Annex 15, and cGMP requirements. You'll lead the design and execution of training programs, AVS, APS, personnel qualification, and contamination control strategies, collaborating with Quality, Validation, and Operations teams. Serve as the Subject Matter Expert (SME) for site sterility assurance concerns, providing invaluable guidance to departments including QC and Manufacturing, and d...