Global Sterility Assurance Systems & Standards Lead

Role: Lead Sterility Assurance within Global Quality Operations, overseeing sterile manufacturing compliance and continuous improvement. Responsibilities: provide strategic leadership on sterility standards, collaborate globally on microbial contamination control, support regulatory intelligence, ensure inspection readiness, and advise on CMO and facility strategies. Lead risk management and drive aseptic excellence across sites and functions. Qualifications: Bachelor’s in microbiology, biology, or related life sciences; 8-10 years in pharma manufacturing with direct QA, microbiology, and sterility assurance experience; strong knowledge of GxP, FDA, EU regulations, and audit practices. HighValue: expertise in sterile filtration, aseptic filling, lyophilization, media fill, bioburden testing; experience with regulatory inspections, deviations, and strategic projects like new filling line development. WorkSetup: global role with cross-functional collaboration; location details not specified.