Materials Management Quality Assurance

BioSpace; Lebanon (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Lilly in Carmel, IN, with permanent site in Lebanon, Indiana, seeks a Material Management Quality Assurance Principal to oversee material and supplier management and ensure compliance with Lilly Quality Standards and regulatory requirements.

You will mentor MMQA and Foundry Materials Management teams, drive supplier qualification, oversee incoming materials, batch release, SAP data stewardship, and support regulatory inspections with a strong focus on continuous process improvement.

Qualifications

• Bachelor's degree in science, engineering, or pharmaceutical field or equivalent experience.
• 3+ years in pharmaceutical quality assurance roles.
• Authorized to work in the United States on a full-time basis; no visa sponsorship provided.

Responsibilities

• Oversee material/vendor management per Lilly Quality Standards and regulatory requirements.
• Develop processes to ensure timely release of raw materials and supplier qualifications.
• Qualify suppliers of raw materials, excipients, GMP consumables and packaging components for GMP operations.
• Support regulatory inspections with documentation and SME input.
• Review GMP documents and track quality metrics.

Skills

Quality Assurance

Regulatory compliance

GMP knowledge

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in science/engineering/pharma

Tools

SAP

Job description

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. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. 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.

Overview

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.

Organization and Position Overview Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, 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 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.

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.

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.

Basic Requirements

• Education Level: Bachelor’s degree in a science, engineering, computer-related, or pharmaceutical field, or equivalent industry experience
• 3+ years working in the pharmaceutical industry in Quality Assurance roles
• 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 Preferences

• 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.

Other Information

• Initial location in Carmel, IN
• Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (