Site Sterility Lead, Associate Director

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** Support sitewide sterility assurance initiatives, ensuring alignment with current regulatory standards including EU GMP Annex 1 (2023), Annex 15, and cGMP requirements. Serve as the Subject Matter Expert (SME) for site sterility concerns, providing invaluable guidance to departments including QC and Manufacturing.With 10+ years of experience in the Biopharma/Pharma Industry, you're well-versed in site microbiology or a related area.Expertise in Eudralex Annex 1 requirements and experience in technical appraisal, document review, and audits.Your analytical and problem-solving skills are top-notch. Strong written and verbal communication abilities set you apart. Proven experience in root cause analysis and risk management. **Secondary** **Language(s) Job Description:**
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