Quality Assurance - Operational Support

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.

Lilly is currently constructing a cutting‑edge facility for the manufacture of new modalities including Gene Therapy. At 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 and 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 design, commission, start up, and maintain the facility for both clinical and commercial supply. This is an exciting opportunity to help build a state‑of‑the‑art facility and Quality System from the ground up.

• ATMP Gene Therapy Drug Substance Manufacturing
• ATMP Gene Therapy Parenteral Manufacturing
• QC Laboratory
• Packaging
• Warehouse Logistics
• Facility, Utility and Maintenance

• Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance

• Act as a cGMP liaison, working with Global Facility Delivery and Lilly project staff to complete the detailed design of the assigned areas employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design

• Consult with Network and Global quality groups as required to ensure consistent and compliant approach is executed during the project and startup phase

• Actively participate in required design reviews and final design qualification activities

• Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures

• Provide quality oversight for the verification and qualification of the manufacturing equipment and facilities, including review of test cases, test execution, discrepancy resolution, etc.

• Work with the Site Quality Leadership to support the development of the vision and strategy for the overall site quality operation and cross‑functional support with focus on the Manufacturing areas

• Support the site organization in building technical capability, for a diverse cross‑functional staff in Quality, the project team, and area process teams, including mentoring and training of new Quality and other project staff

• 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 including support of site self‑inspections in GQA

• Lead project initiatives needed in support of the project and Quality function

• Resolve or elevate any compliance issues to the project, site, and Quality Management

• Provides guidance for deviations, observation handling; change control proposals; document creation and revisions.

• Bachelor’s degree in relevant field (preference for scientific or engineering field)

• 3+ years working in the pharmaceutical manufacturing industry in Quality Assurance roles

• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation

• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of pharmaceutical manufacturing

• ASQ Certified

• Computer System Quality Assurance experience

• Previous facility or area start up experience

• Previous experience with gene therapy drug substance processes such as equipment prep, virus…