Lilly is seeking a Principal/Senior Associate, QA for API External Manufacturing to provide quality oversight for contract manufacturers producing active pharmaceutical ingredients. In this role, you will ensure compliance with cGMP, Lilly quality standards, and global regulatory requirements. Responsibilities include review and approval of batch records, deviations, CAPAs, and change controls; assessing and monitoring CMO performance; supporting regulatory inspections and audits; and driving continuous improvement in quality systems. You will collaborate cross-functionally to ensure reliable, compliant supply of high-quality API for Lilly's medicines. Responsibilities Provide QA oversight for external API manufacturing sites and CMOs Ensure adherence to c GMP, Lilly quality standards, and regulatory requirements Review and approve batch records, deviations, CAPAs, and change controls Monitor and assess CMO quality performance and compliance metrics Support and lead regulatory inspections, audits, and CMO quality reviews Collaborate with technical, supply chain, and regulatory teams to maintain reliable supply Drive continuous improvement in quality systems and processes Evaluate and mitigate quality and compliance risks related to external manufacturing Required Skills GMP compliance API manufacturing oversight Quality systems management Deviation and CAPA management Regulatory inspection readiness Quality risk management Batch record review and release Supplier and CMO quality management

ICH Q7/Q10

guidelines Change control