Principal - QA API External Manufacturing Peptides

Role: Quality Assurance lead for API external manufacturing at Lilly, ensuring compliance with cGMP and regulatory standards. Responsibilities: oversee QA activities at third-party API manufacturing sites, including batch review, deviation investigations, change control, and document approval; conduct and support audits; collaborate with internal teams and external partners; develop quality agreements; support new product introductions and tech transfers; investigate quality incidents and represent Lilly during regulatory inspections; mentor junior QA staff. Requirements: Bachelor's in Chemistry, Biochemistry, Pharmacy, or related; at least 5 years in pharmaceutical QA with API manufacturing and external supply experience; strong knowledge of cGMP, global pharmacopeial standards, and auditing; proficiency in quality management systems (e.g., Veeva); willingness to travel domestically and internationally. Preferred: deep understanding of API manufacturing processes, analytical methods, and quality control; excellent problem-solving and communication skills; ability to work independently in a fast-paced environment. High-Value: API manufacturing, external site oversight, cGMP compliance, audits, regulatory inspection support, 5+ years experience, QA leadership, global supply chain. WorkSetup: on-site at Indianapolis, IN, or Durham, NC; travel required.