PAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve disease understanding and management, and give back through philanthropy and volunteerism. We are committed to putting people first and delivering our best effort. /ppWe are seeking a Quality Assurance professional with experience in drug product manufacturing and batch disposition. The role involves responsibilities related to the start-up of new External Manufacturing relationships, support for existing relationships and products, and ensuring quality standards are met across all activities. /ph3Main Responsibilities /h3pThe successful candidate will act as the primary Lilly quality contact for: /pulliProviding quality support for existing products and external manufacturers (EMs). /liliEnsuring EMs follow appropriate quality systems, including change control and deviation management, through visits, communication, and performance monitoring. /liliBuilding and maintaining effective communication with EMs, reporting issues and progress to management. /liliVisiting EMs regularly to review operations and produce visit reports. /liliExecuting quality systems tasks such as batch dispositions, deviation and change control evaluations, and product quality investigations. /liliManaging laboratory accreditation processes and analytical method transfers. /liliParticipating in product reviews, stability programs, and quality evaluations. /liliMonitoring supply chains, vendor approvals, and conducting vendor audits. /liliReviewing and maintaining product specifications, quality agreements, and master batch records. /liliIdentifying and leading quality improvement initiatives, managing corrective actions, and ensuring compliance with technical and regulatory requirements. /liliCollaborating with local affiliates and participating in performance reviews, audits, and joint teams. /liliSupporting commercialization activities for new products and capacity expansion at EMs. /li /ulpThis role requires proactive engagement in quality assurance activities, collaboration with cross-functional teams, and a strong focus on compliance and continuous improvement. /p #J-18808-Ljbffr