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