Senior Associate - External Manufacturing QA
Eli Lilly and Company
August 08, 2026
On-site
Lebanon, IN
Operations
Responsibilities:
- Liaise 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.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Evaluate/disposition drug substance, drug product, and packaging batches (COTs, environmental monitoring where applicable, deviations, changes, batch documentation).
- Provide quality support via holistic review of key manufacturing activities.
- Monitor external regulatory findings impacting product quality.
- Review/approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
- Provide onsite support as required; support CM regulatory inspections.
- Participate in APR and Post Launch Optimization Teams (PLOT).
Basic Requirements:
- Bachelor’s degree (preference scientific/engineering).
- 3+ years in pharmaceutical manufacturing Quality Assurance.
- Prior QA oversight experience for contract manufacturers.
- Authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of US/EU/Japan pharmaceutical manufacturing regulations; ASQ Certified.
- Facility/area start-up experience; gene therapy process and/or drug product manufacturing experience.
- Experience with Manufacturing Execution Systems.
- Strong communication, problem-solving, technical writing, and ability to train/mentor.
Additional Information:
- 8–12 hour shifts, Mon–Fri (Lebanon, IN); travel 10–25%.
- Eligible for company bonus and comprehensive benefits (401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).
- Liaise 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.
- Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Evaluate/disposition drug substance, drug product, and packaging batches (COTs, environmental monitoring where applicable, deviations, changes, batch documentation).
- Provide quality support via holistic review of key manufacturing activities.
- Monitor external regulatory findings impacting product quality.
- Review/approve procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
- Provide onsite support as required; support CM regulatory inspections.
- Participate in APR and Post Launch Optimization Teams (PLOT).
Basic Requirements:
- Bachelor’s degree (preference scientific/engineering).
- 3+ years in pharmaceutical manufacturing Quality Assurance.
- Prior QA oversight experience for contract manufacturers.
- Authorized to work in the United States full-time; Lilly does not sponsor visas.
Additional Preferences:
- Knowledge of US/EU/Japan pharmaceutical manufacturing regulations; ASQ Certified.
- Facility/area start-up experience; gene therapy process and/or drug product manufacturing experience.
- Experience with Manufacturing Execution Systems.
- Strong communication, problem-solving, technical writing, and ability to train/mentor.
Additional Information:
- 8–12 hour shifts, Mon–Fri (Lebanon, IN); travel 10–25%.
- Eligible for company bonus and comprehensive benefits (401(k), pension, vacation, medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).