Experteer Overview La preghiamo di leggere attentamente le informazioni contenute in questo annuncio di lavoro per comprendere esattamente cosa ci si aspetta dai potenziali candidati. In 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. Retribuzione / Benefits Provide technical leadership over QA systems in the QC microbiology lab, including method validation and equipment qualification Lead investigations for sterility, bioburden, endotoxin, bioassay deviations, and container closure issues Evaluate and implement Global Quality Standards and Pharmacopoeia updates; coordinate globally Serve as SME during internal and external inspections and ensure inspection readiness Oversee contract laboratories for microbiological testing and issue resolution Coordinate microbiology projects and new product launches; support regulatory affairs with QC expertise Engage in international networks (APLOTs, GPLOTs, GQL, lab networks) and contribute to analyst development Review/approve procedures and change controls; back-up for analytical result release Responsabilità At least 8 years of pharmaceutical industry experience in microbiology and GMP QC operations Deep knowledge of FDA/EMA guidelines, Pharmacopoeia requirements, xivgfpx and ISO standards Proven ability to lead investigations and manage cross-functional projects Experience interfacing with global quality teams and external associations Requisiti fondamentali Competitive base salary with annual incentive Relocation package Comprehensive benefits including extensive insurance Annual salary review and advancement opportunities Stock option package Hybrid/onsite work arrangement (on-site with 4 days of remote work per month) #J-18808-Ljbffr