Quality Assurance Operational Support

Role: Quality Assurance Operational Support Representative for Lilly’s new advanced therapies manufacturing site, focusing on gene therapy modalities in Lebanon, Indiana. Objectives include ensuring GMP compliance, supporting facility startup, and maintaining quality systems for clinical and commercial supply. Responsibilities: provide technical and quality review of documents, oversee equipment verification, lead investigations of deviations, change controls, and batch record reviews, and support regulatory inspections. Lead/support process initiatives, promote a strong quality culture, and monitor GMP adherence on-site. Requirements: Bachelor’s in science, engineering, or related field; 3+ years in pharmaceutical QA roles; experience with GMP, regulatory standards (US, EU, Japan), and equipment validation. Preferred: knowledge of gene therapy manufacturing processes, technical writing skills, and proficiency with systems like Veeva Vault, SAP, and automation platforms. HighValue: gene therapy modalities, manufacturing startup, GMP compliance, equipment validation, regulatory inspection support, cross-functional team collaboration. WorkSetup: not specified; likely on-site in Lebanon, Indiana.