Senior/ Principal - Materials Management QA

Job Summary

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. This is hard, urgent, selfless work-but it s work worth doing. If you re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Materials Management and Quality Assurance Representative - Device Assembly and Packaging

Role Overview

This role provides support to the Indianapolis Device Assembly and Packaging (IDAP) materials management systems. The Materials Management representative provides Quality Oversight for the suppliers and materials utilized by the IDAP Site. This position supports all Materials Management activities related to IDAP Products to ensure appropriate Quality Oversight

Key Responsibilities

• Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.
• Conduct material and supplier risk assessments and periodic reviews of supplier performance.
• Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements.
• Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.
• Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints).
• Provide input and guidance to site activities (e.g. six sigma, new product / process development, change controls) as material quality SME.
• Be able to perform materials SAP data steward functions, if necessary.
• Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.
• Provide the voice of quality to the IDAP Supplier Committee, providing input and support as needed in order to ensure compliance.
• Support regulatory inspection activities as needed by providing documentation and SME support.
• Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.
• Work with global resources, as necessary, to achieve compliance with requirements.
• Lead, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.

Minimum Experience

• Demonstrated relevant experience in a GMP facility.
• Proficiency with current computer systems and applications including Microsoft Office products, SAP, EDMS and TrackWise or similar systems.
• Strong oral and written communication and interpersonal skills.
• Ability to influence externally with suppliers and resources across sites.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Preferences

• Experience with Lilly deviation and change control processes.
• Experience in material management, quality systems and cGMPs

Education Experience

• Bachelor s degree or equivalent experience in a science-related field with 5 to 10 years of experience in a relative function.

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