Laboratory Compliance Lead Lilly Medicine Foundry

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.

In the Project Delivery Phase and Startup Phase of the project (2025 to 2028), roles will be fluid and dynamic as we endeavor to support the project delivery, build a new organization, develop and implement the necessary systems and business processes required to support GMP operations. This will require significant collaboration, creativity and resilience as the Lilly Medicine Foundry goes from design, to start-up, and to steady-state operations.

Job Summary

The Lab Compliance Lead ensures the quality, compliance, and operational readiness of laboratory environment. This role provides quality oversight across laboratory operations, systems, equipment, and documentation to ensure adherence to cGMP, GLP, internal quality standards, and global regulatory expectations.

Working closely with Laboratory Operations, R&D scientists, Manufacturing, Facilities, IT, and Automation the Lab Compliance Specialist enables compliant, inspection‑ready laboratories while supporting continuous improvement, data integrity, and efficient laboratory execution throughout the product lifecycle.

Key Responsibilities

Laboratory Quality Oversight

• Perform routine and non‑routine QA reviews of laboratory documentation, including analytical records, calibration logs, equipment maintenance records, and logbooks, ensuring accuracy, completeness, and compliance.

• Provide quality oversight of laboratory processes such as sample management, analytical testing, data review, and laboratory workflows.

• Ensure laboratory activities are executed in alignment with cGMP, GLP, internal procedures, and site quality expectations.

Laboratory Operations & Readiness Support

• Partner with Lab Operations to support day‑to‑day laboratory activities while maintaining a strong quality and compliance posture.

• Support laboratory readiness activities, including lab start‑up, expansion, renovation, and transitions between GMP and non‑GMP operations.

• Provide QA input into laboratory layout, workflow design, and operational practices to ensure compliance and inspection readiness.

• Support technology transfer and method transfer activities by. ensuring laboratory operational readiness and appropriate quality controls.

Equipment & Asset Lifecycle Oversight

• Provide quality oversight for the full laboratory equipment lifecycle, including installation, qualification (IQ/OQ/PQ), calibration, preventive maintenance, and decommissioning.

• Review and approve equipment qualification packages, validation documentation, service records, and equipment logbooks.

• Partner with Lab Operations to ensure accurate asset tracking, inventory management, maintenance scheduling, and retention of equipment history.

Deviation, OOS, and CAPA Management

• Participate in and support investigations of laboratory deviations, out‑of‑specification (OOS), and out‑of‑trend (OOT) results.

• Facilitate root cause analysis and ensure corrective and preventive actions (CAPAs) are appropriate, effective, and verified.

• Track investigations and CAPAs to closure and ensure alignment with quality system requirements.

Audits & Inspections

• Conduct internal audits of laboratory processes and quality systems to identify compliance gaps, risks, and opportunities for improvement.

• Support internal and external audits and regulatory inspections, acting as a subject matter expert for laboratory quality systems and operations.

• Ensure laboratories remain in a state of inspection readiness.

Documentation, SOPs & Change Management

• Develop, review, and revise SOPs, work instructions, and quality agreements related to laboratory operations, equipment use, and quality systems.

• Support change control activities associated with laboratory processes, equipment, digital systems, and operational. improvements.

• Ensure documentation accurately reflects current practices and regulatory expectations.

Digital & Laboratory Systems Oversight

• Provide quality oversight of laboratory digital systems, including LIMS, electronic notebooks, equipment software, and data flows between instruments and long‑term storage systems.

• Ensure laboratory systems are appropriately validated, controlled, and used in compliance with data integrity and regulatory requirements.

Training, Metrics & Continuous Improvement

• Provide quality training to laboratory personnel on cGMP principles, data integrity, and laboratory quality systems.

• Monitor, trend, and report key laboratory quality and operational metrics.

• Identify opportunities for continuous improvement and partner with cross‑functional teams to implement sustainable solutions.

Minimum Qualifications

• Bachelor's degree in a scientific discipline (Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related field).

• 3-5 years of experience in Quality Assurance within a regulated laboratory environment (pharmaceutical or biotech)

• Strong working knowledge of cGMP, GLP, and applicable regulatory requirements

• Hands‑on experience with laboratory quality systems, including deviations, CAPA, change control, and document control.

• Experience supporting laboratory operations, equipment qualification, and audit readiness.

• Proficiency with LIMS and electronic quality management systems (eQMS).

• Strong analytical, problem‑solving, and communication skills.

• Ability to work independently and collaboratively in a fast‑paced environment.

• 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

Other Information:

• Initial location at Lilly Technology Center, Indianapolis.

• Permanent location at the new Lilly Medicine Foundry in Lebanon, Indiana.

• Flexibility to work from Indianapolis (or other Lilly sites) may be required through out 2026 and 2029

• Position requires on-site presence, 8-hour days, five days per week, with flexibility to support activities during shutdowns, weekends, etc.

• 0-10% travel required.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $148,500

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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