Materials Management Quality Assurance

Lilly • Indianapolis, IN

8d • $66,000 - $171,600

About The Position

The Materials Management Quality Assurance Principal oversees material and vendor management processes to ensure compliance with Lilly Quality Standards and applicable regulatory requirements. The role works with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers, manage programs, improve operations, and support warehouse functions such as material receipt, sampling, and batch release. It supports the Lilly Medicine Foundry, an advanced manufacturing and drug development center combining research and manufacturing.

Requirements

• Bachelor’s degree in a science, engineering, computer-related, or pharmaceutical field, or equivalent industry experience.
• At least 3 years of pharmaceutical industry experience in Quality Assurance roles.
• Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

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

Responsibilities

• Serve as a materials management expert, mentoring and advising MMQA, Foundry Materials Management, and PR&D.
• Partner with business teams and MMQA colleagues to develop processes and strategies for timely release of raw materials, excipients, GMP consumables, and packaging components, and for supplier qualification.
• Oversee and support qualification of suppliers of purchased materials for GMP operations.
• Collaborate with site staff and global resources on risk assessments and recommendations for Supplier/Service Provider approval.
• Participate in periodic supplier performance reviews.
• Write and coordinate Supplier, Service Provider, and Affiliate Quality Agreements.
• Represent the voice of quality on material management and supplier certification committees.
• Provide operational oversight for incoming receipt, sampling, and testing.
• Perform batch disposition of incoming materials and consumables.
• Perform SAP data steward functions.
• Review and redline GMP documents, including specifications and procedures.
• Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and the Materials Management Governance Committee.
• Support regulatory inspections by providing documentation and subject matter expertise.
• Evaluate potential product quality impact for GMP-related incidents, perform initial assessments, and support investigations to establish root causes and effective corrective and preventive actions.
• Immediately notify management of critical departures and ensure resulting issues are effectively managed.
• Maintain the Foundry's audit readiness and participate in internal and external inspections.
• Perform other related duties as assigned.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior