Materials Management Quality Assurance

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 effectively managed.
• Ensure the Foundry is always audit ready and participate in internal/external inspections.
• Perform other related duties as assigned.

Basic Requirements

• Bachelor's degree in a science, engineering, computer-related, or pharmaceutical field, or equivalent industry experience
• 3+ years working in the pharmaceutical industry in Quality Assurance roles
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role.

Additional Preferences

• Previous experience working with and managing suppliers and materials in a regulated environment.
• Previous experience with SAP or other inventory/materials management systems.
• Demonstrated knowledge and use of US, EU, Japanese and other regulations as they pertain to areas in the pharmaceutical manufacturing and material/supplier management.
• Experience supporting facility or area start up experience is preferred.
• Skilled in handling deviation and change management records, overseeing evaluation, approval, and complex quality events.
• Demonstrated ability to communicate with and influence cross-functional teams, including good oral and written communication skills.
• Demonstrated strong problem solving and decision-making skills.
• Technical writing experience, including authoring, reviewing, and approving complex GMP documents and quality system procedures.
• Technical aptitude and ability to train and mentor others.

Other Information

Initial location in Carmel, IN. Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.