Principal/Sr. Associate-QA-API External Manufacturing

Role: API EM Quality Assurance Consultant supporting quality activities at Contract Manufacturing organizations (CMs) for Lilly's pharmaceutical API manufacturing. Responsibilities: serve as a liaison between CMs and Lilly, oversee quality compliance of batches, manage quality documentation, participate in regulatory inspections, and review deviations, change controls, and batch records. Contribute to quality support for API manufacturing and improve processes through cross-functional participation. Requirements: Bachelor's in science (e.g., Chemistry, Pharmacy, Biological Sciences); minimum 2 years GMP API or pharmaceutical manufacturing QA or QC experience; authorized to work full-time in the US. Preferred: experience in quality control support, understanding of pharma manufacturing operations, root cause analysis, statistical skills, and strong communication. HighValue: GMP/API manufacturing, quality oversight, regulatory inspection support, QA document review, API shipment coordination. WorkSetup: on-site, supporting 24-hour operations; travel up to 20% (intercontinental possible).