Quality Assurance - Material​/Supplier Management

Overview

Quality Assurance - Material/Supplier Management role at Bio Space

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.

At Lilly, we are constructing a cutting-edge facility for the manufacture of new modalities including Gene Therapy. Located in Lebanon, IN, the Lebanon Advanced Therapies (LP2) facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products  will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a gene therapy manufacturing site in a highly cross-functional environment. The successful candidate will demonstrate leadership, teamwork, and technical expertise in the onboarding of materials/suppliers required for the Site mission and then provide ongoing oversight for the program.

Position Description

The MMQA Representative oversees the material/vendor management system for the Lilly Advanced Therapies Site, ensuring compliance with Lilly Quality Standards. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Responsibilities include program execution/maintenance, improvement, and support for incoming material receipt, batch release, and warehouse 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 SME support

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience
• 3+ years working in the pharmaceutical industry in Quality Assurance roles

• Previous experience working with and managing suppliers and materials in a regulated environment
• Previous experience with SAP or other inventory management systems
• Demonstrated knowledge and use of US, EU, Japanese and other regulations in the area of pharmaceutical manufacturing and material/supplier management
• Previous facility or area start up experience
• Previous experience with deviation and change management systems
• 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
• Previous technical writing experience
• Technical aptitude and ability to train and mentor others

• 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

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