Quality Assurance - Material/Supplier Management

Role Summary

The MMQA Representative oversees the material/vendor management system for the Lilly Advanced Therapies Site, ensuring compliance with Lilly Quality Standards. They collaborate with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers, and provide program execution/maintenance, improvement, and support for incoming material receipt, batch release, and warehouse operations. This role supports startup activities for a gene therapy manufacturing site in Lebanon, IN and provides ongoing oversight for the program.

Responsibilities

• 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 SME support

Qualifications

• Required: Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
• Required: 3+ years working in the pharmaceutical industry in Quality Assurance roles
• Preferred: Previous experience working with and managing suppliers and materials in a regulated environment
• Preferred: Previous experience with SAP or other inventory management systems
• Preferred: Demonstrated knowledge and use of US, EU, Japanese and other regulations in pharmaceutical manufacturing and material/supplier management
• Preferred: Previous facility or area startup experience
• Preferred: Previous experience with deviation and change management systems
• Preferred: Ability to communicate with and influence cross-functional teams; strong oral and written communication skills
• Preferred: Strong problem solving and decision making skills
• Preferred: Technical writing experience; ability to train and mentor others

Education

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience

Additional Requirements

• Ability to work 8-12 hour shifts on Monday-Friday in the Lebanon, IN office
• Position may require travel (10-25%) or potentially a short duration assignment at another Lilly site to establish material management system knowledge