Materials Management Quality Assurance

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Overview: At 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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Organization and Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Material Management Quality Assurance (MMQA) Principal oversees material/vendor management process ensuring compliance with Lilly Quality Standards and applicable regulatory requirements. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Key responsibilities involve managing programs, facilitating operational enhancements, and providing support for warehouse functions such as material receipt, sampling, and batch release. Responsibilities Serve as a materials management expert, mentoring and advising MMQA, Foundry Materials Management, and PR&D. Work with business partners and MMQA colleagues to develop processes and strategies to ensure timely release of raw materials, excipients, GMP consumables and packaging components and supplier qualifications to support business needs. Oversight and support of qualification of all suppliers of purchased materials (raw materials, excipients, GMP consumables and packaging components) for use in GMP operations. Collaborate with site staff and global resources to assist/conduct risk assessments and provide recommendations for Supplier/Service Provider approval. Participate in periodic reviews of supplier performance. Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements. Represent the voice of quality to material management and supplier certification committees. Provide operational oversight for incoming receipt, sampling, and testing. Perform batch disposition of incoming materials/consumables. Perform SAP data steward functions. Review/redline GMP documents including specifications and procedures. Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee. Support regulatory inspections by providing documentation and Subject Matter Expert support. Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA). Notify management immediately about any critical departures and make sure the resulting issues are …

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