Quality Assurance Operational Support

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.

Lilly is currently constructing a cutting‑edge facility for the manufacture of new modalities including Gene Therapy in Lebanon, Indiana. This facility will be Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products  will include next‑generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety, quality, and process performance.

This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to start up the facility for both clinical and commercial supply.

This is an exciting opportunity to help start up a state‑of‑the‑art facility and build a manufacturing supply chain from ground‑up.

The Quality Assurance Operational Support Representative is responsible for demonstrating leadership, teamwork, and quality/regulatory knowledge to provide oversight for the delivery and daily operation of the Lilly Advanced Therapies (LP2) site. The QA Operational Support Representative provides guidance to issues such as non‑conformance investigations, change control proposals, procedure / master formula revisions, validations, batch disposition, commissioning, and qualification activities. The Quality Assurance Operational Support Representative is essential for maintaining GMP compliance and providing support during preparation for Pre‑Approval / General Inspections by various regulatory agencies.

• Adhere to safety rules and maintaining a safe work environment for both you and others by supporting HSE corporate and site goals
• Provide technical and quality review and approval of documents to ensure compliance with Lilly Global Quality Standards and local procedures
• Oversee verification of manufacturing equipment/facilities from definition of requirements thru design and testing
• Lead, mentor, and coach operations and support personnel on quality matters, e.g. good documentation practices, data integrity and regulatory compliance.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
• Support the definition and execution of inspection readiness activities and provide support for internal / external regulatory inspections
• Lead/support Process Team initiatives needed in support of the Site and Quality function
• Ensure regular presence in operational areas to monitor GMP programs and quality systems
• Provide guidance and triage for deviations and change controls
• Support and/or execute review of batch records and release of drug substance, drug product, and finished product batches for Clinical Trial and commercial use
• Consult with Network and Global quality groups as required to ensure consistent and compliant approach to facility delivery and operation

• Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
• 3+ years working in the pharmaceutical manufacturing industry…