Senior Associate - External Manufacturing QA
Eli Lilly and Company
June 26, 2026
On-site
Lebanon, IN
Operations
Responsibilities:
- Serve as liaison between contract manufacturers (CMs) and Lilly; initial point of contact for quality issues.
- Escalate CM quality issues to Lilly QA management.
- Assist with establishing/revising Quality Agreements with affiliates/customers; ensure compliance to Quality Agreements and MRDs.
- Evaluate and disposition drug substance, drug product, and packaging batches (Certificates of Testing/Environmental Monitoring where applicable, deviations, changes, and batch documentation).
- Provide quality support via holistic review of manufacturing activities impacting processes.
- Monitor external regulatory agency findings related to product quality.
- Review/approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
- Provide onsite support; support regulatory inspections with CMs.
- Participate in APR activities and Post Launch Optimization Teams (PLOT).
Basic Requirements:
- Bachelor’s degree in a relevant field (preference: scientific/engineering).
- 3+ years in pharmaceutical manufacturing Quality Assurance roles.
- Experience overseeing QA for contract manufacturers.
- Must be authorized to work in the U.S. on a full-time basis; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of US/EU/Japan and other pharmaceutical manufacturing regulations; ASQ certification.
- Facility/area start-up experience; gene therapy process and MES experience.
- Strong communication, problem-solving, decision-making, technical writing, and ability to train/mentor.
Additional Information:
- 8–12 hour shifts, Mon–Fri (Lebanon, IN). Travel 10–25%.
Compensation/Benefits (as listed):
- Anticipated wage: $65,250–$169,400; potential company bonus; eligible for benefits including 401(k), pension, medical/dental/vision, life insurance, time off/leave, and well-being benefits.
- Serve as liaison between contract manufacturers (CMs) and Lilly; initial point of contact for quality issues.
- Escalate CM quality issues to Lilly QA management.
- Assist with establishing/revising Quality Agreements with affiliates/customers; ensure compliance to Quality Agreements and MRDs.
- Evaluate and disposition drug substance, drug product, and packaging batches (Certificates of Testing/Environmental Monitoring where applicable, deviations, changes, and batch documentation).
- Provide quality support via holistic review of manufacturing activities impacting processes.
- Monitor external regulatory agency findings related to product quality.
- Review/approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
- Provide onsite support; support regulatory inspections with CMs.
- Participate in APR activities and Post Launch Optimization Teams (PLOT).
Basic Requirements:
- Bachelor’s degree in a relevant field (preference: scientific/engineering).
- 3+ years in pharmaceutical manufacturing Quality Assurance roles.
- Experience overseeing QA for contract manufacturers.
- Must be authorized to work in the U.S. on a full-time basis; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of US/EU/Japan and other pharmaceutical manufacturing regulations; ASQ certification.
- Facility/area start-up experience; gene therapy process and MES experience.
- Strong communication, problem-solving, decision-making, technical writing, and ability to train/mentor.
Additional Information:
- 8–12 hour shifts, Mon–Fri (Lebanon, IN). Travel 10–25%.
Compensation/Benefits (as listed):
- Anticipated wage: $65,250–$169,400; potential company bonus; eligible for benefits including 401(k), pension, medical/dental/vision, life insurance, time off/leave, and well-being benefits.