Sr. Associate Materials Management QA

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.

Facility Overview

The Lilly Medicine Foundry is 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 Lilly 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.

Job Position Overview

The Materials Management Quality Assurance (MMQA) Sr. Associate supports the material and vendor management processes to help ensure compliance with Lilly Quality Standards and applicable regulatory requirements. This role works closely with supply chain, customer service, procurement, and warehouse operations to assist in assessing and supporting approval activities for materials and suppliers. Key responsibilities are program support, improvement participation, and operational quality for warehouse tasks like material receipt, sampling, and batch release.

As the Foundry is currently in design and construction, this position will provide Quality support for the detailed design and quality processes related to materials and vendor management processes as well as warehouse operational readiness activities. The position will participate in ensuring that the quality management system is established and adhered to for this area.

Responsibilities

• Support business partners and MMQA colleagues in executing processes that enable timely release of raw materials, excipients, GMP consumables, packaging components, and supplier qualification activities needed to meet business demands.
• Assist with qualification activities for suppliers of purchased materials (raw materials, excipients, GMP consumables, and packaging components) by collecting documentation, preparing assessments, and coordinating reviews needed for use in GMP operations.
• Collaborate with site staff and global resources to support risk assessments and contribute to recommendations for Supplier/Service Provider approval.
• Participate in periodic supplier performance reviews by preparing data summaries and supporting documentation.
• Draft, route, and maintain Supplier, Service Provider, and Affiliate Quality Agreements with guidance from senior team members.
• Provide quality support to materials management operations, including participation in supplier certification‑related activities as requested.
• Support incoming material receipt, sampling, and testing workflows to ensure compliance with procedures.
• Execute batch disposition of incoming materials and consumables in accordance with defined quality requirements.
• Perform SAP data steward functions including data entry, verification, and updates.
• Review and redline GMP documents such as specifications and procedures with oversight as needed.
• Maintain data for materials management metrics and provide updates to appropriate stakeholders.
• Assist during internal and external regulatory inspections by retrieving documentation and supporting preparation activities.
• Support evaluation of GMP‑related incidents by performing initial assessments and contributing to investigation activities including RCA and CAPA documentation.
• Escalate issues to management when appropriate and assist with follow‑up actions.
• Contribute to ongoing audit readiness and participate in inspection‑related activities as assigned.
• Perform other related duties as assigned.

Basic Requirements

• Bachelor's degree in science, engineering, computer, or related field of study and 1-3 years' experience supporting Quality Assurance in pharmaceutical manufacturing or biotech industry.
• Strong oral and written communication skills, with the ability to work effectively across cross‑functional teams.
• 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, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences

• Previous experience wor