Ph3Experteer Overview /h3pIn this role you will lead microbiology and QC laboratory operations to ensure GMP and global regulatory compliance. You’ll act as a technical authority, support inspections, and manage quality systems and investigations with cross-functional teams. The position offers impact across method validation, equipment qualification, and external collaborations, contributing to Lilly’s mission to improve patient outcomes. A strong focus on global quality standards and sterility assurance provides a meaningful, wide-ranging scope. /ph3Retribuzione / Benefits /h3ulliProvide technical leadership over QA systems in the QC microbiology lab, including method validation and equipment qualification /liliLead investigations for sterility, bioburden, endotoxin, bioassay deviations, and container closure issues /liliEvaluate and implement Global Quality Standards and Pharmacopoeia updates; coordinate globally /liliServe as SME during internal and external inspections and ensure inspection readiness /liliOversee contract laboratories for microbiological testing and issue resolution /liliCoordinate microbiology projects and new product launches; support regulatory affairs with QC expertise /liliEngage in international networks (APLOTs, GPLOTs, GQL, lab networks) and contribute to analyst development /liliReview/approve procedures and change controls; back-up for analytical result release /li /ulh3Responsabilità /h3ulliAt least 8 years of pharmaceutical industry experience in microbiology and GMP QC operations /liliDeep knowledge of FDA/EMA guidelines, Pharmacopoeia requirements, and ISO standards /liliProven ability to lead investigations and manage cross-functional projects /liliExperience interfacing with global quality teams and external associations /li /ulh3Requisiti fondamentali /h3ulliCompetitive base salary with annual incentive /liliRelocation package /liliComprehensive benefits including extensive insurance /liliAnnual salary review and advancement opportunities /liliStock option package /liliHybrid/onsite work arrangement (on-site with 4 days of remote work per month) /li /ul /p #J-18808-Ljbffr