Principal/Sr. Associate-QA-API External Manufacturing

Role: API EM Quality Assurance Consultant supporting quality activities at Contract Manufacturing organizations (CMs). Objectives: ensure batches meet specifications, comply with cGMP, and adhere to regulatory commitments. Responsibilities: act as a liaison between CMs and Lilly, oversee quality issues, review and approve batch documentation, participate in inspections and regulatory interactions, evaluate and disposition API batches, and support continuous quality improvements. Requirements: Bachelor’s in Pharmacy, Chemistry, Biological Sciences, or related field; minimum 2 years GMP manufacturing experience in API or pharmaceuticals, QA, or technical roles; authorized to work full-time in the U.S. Additional Preferences: experience in quality control support, robust understanding of pharma manufacturing and quality systems, root cause analysis, statistical skills, strong communication, and interpersonal skills. High-Value: API manufacturing, cGMP compliance, regulatory inspection support, quality oversight of API shipments, and cross-functional collaboration. Work setup: full-time, support for 24-hour operations, with ~20% travel.