Principal - Material Management Quality Assurance

Eli Lilly and Company • Lebanon, IN

10d • $65,250 - $169,400

About The Position

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 Material Management Quality Assurance (MMQA) Principal oversees material/vendor management process ensuring compliance with Lilly Quality Standards and applicable regulatory requirements. They work with supply chain, customer service, procurement, and warehouse operations to assess and approve materials and suppliers. Key responsibilities involve managing programs, facilitating operational enhancements, and providing support for warehouse functions such as material receipt, sampling, and batch release. As the Foundry is currently in design and construction, this position will provide Quality oversight 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.

Requirements

• Bachelor's degree in science, engineering, computer or related field of study and 3+ years of experience supporting Quality Assurance working in pharmaceutical manufacturing or biotech experience.
• 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.

Nice To Haves

• Previous experience working with and managing suppliers and materials in a regulated environment.
• Previous experience with SAP or other inventory/materials management systems.
• Demonstrated knowledge and use of US, EU, Japanese and other regulations as they pertain to areas in the pharmaceutical manufacturing and material/supplier management.
• Experience supporting facility or area start up experience is preferred.
• Skilled in handling deviation and change management records, overseeing evaluation, approval, and complex quality events.
• 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.
• Technical writing experience, including 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.
• Work with business partners and MMQA colleagues to develop processes and strategies to ensure timely release of raw materials, excipients, GMP consumables and packaging components and supplier qualifications to support business needs.
• Oversight and support of qualification of all suppliers of purchased materials (raw materials, excipients, GMP consumables and packaging components) for use in GMP 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 Subject Matter Expert support.
• Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
• Notify management immediately about any critical departures and make sure the resulting issues are effectively managed.
• Ensure the Foundry is always audit ready and participate in internal/external inspections.
• Perform other related duties as assigned.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

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