* Serve as the primary Quality Assurance point of contact for assigned API external manufacturing sites, fostering strong collaborative relationships.
* Review and approve manufacturing documentation, including master batch records, executed batch records, deviations, investigations, CAPAs, change controls, and OOS reports, to ensure cGMP compliance and product quality.
* Participate in and lead quality audits of external manufacturing partners to assess compliance with cGMPs, regulatory requirements, and internal quality systems.
* Oversee and approve critical quality events, including significant deviations, investigations, and CAPAs, ensuring timely and effective resolution.
* Collaborate with internal cross-functional teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) to support new product introductions, technology transfers, and continuous improvement initiatives at external manufacturing sites.
* Monitor key quality metrics and performance indicators for assigned external manufacturers, identifying trends and implementing corrective actions as needed.
* Contribute to the development, implementation, and maintenance of quality agreements with external manufacturing partners.
* Ensure all externally manufactured APIs meet Eli Lilly and Company’s quality standards and regulatory requirements for release.
* Support regulatory inspections and provide responses to regulatory inquiries related to external manufacturing activities.
* Maintain current knowledge of cGMP regulations (e.g., FDA, EMA) and industry best practices relevant to API manufacturing and external supply chain quality.