Materials Management Quality Assurance

About This Role

This role oversees the material and vendor management process, ensuring compliance with Lilly Quality Standards and applicable regulatory requirements. It involves working with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers, and 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
• Oversee and support 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

About the Company

Lilly unites caring with discovery to help make life better for people around the world. Headquartered in Indianapolis, Indiana, its over 50,000 employees around the globe discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities it serves. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development.