Pubblicato il 17 giugno
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Experteer Overview
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, 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)
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