Principal/Sr. Associate-QA-API External Manufacturing
Eli Lilly and Company
August 18, 2026
Remote friendly (Indianapolis, IN)
United States
Operations
Key Objectives/Deliverables:
- Serve as a liaison between contract manufacturing organizations (CMs) and Lilly; be initial point of contact for quality issues.
- Provide quality oversight of CMs; escalate quality issues to Lilly QA management.
- Assist with establishing/revising Quality Agreements; ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Provide oversight of Lilly/API EM Quality Plans.
- Coordinate and perform QA responsibilities for API shipments from suppliers and CMs.
- Prepare for regulatory inspections with CMs; provide on-site support.
- Participate on the Technical Review Board; evaluate/disposition API batches (if required).
- Ensure documented checks are completed (incl. Certificates of Testing/Environmental Monitoring where applicable) and that deviations/changes/batch documentation meet requirements before release.
- Provide quality support for API manufacturing (review deviations, change controls, countermeasures); assess impacts of investigations/changes and ensure retrievable records.
- Ensure processes remain in control; monitor external regulatory findings.
- Review/approve documents (procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, computerized system validations).
- Participate in APR, productivity projects, Joint Process (JPT), and Post Launch Optimization (PLOT) Teams.
Basic Requirements:
- Bachelor’s degree in a science-related field.
- 2+ years GMP manufacturing experience in API or pharma experience (finished product, QC/QA, or Engineering).
- Authorized to work in the U.S. full-time (no visa sponsorship).
Additional Preferences:
- Quality support for QC, knowledge of quality systems/regulatory requirements, pharma manufacturing knowledge, mentoring/coaching, root cause analysis, statistical skills, written/verbal communication, attention to detail, computer proficiency, interpersonal skills, ability to prioritize, and influence/manage relationships.
Other Information:
- Complete required API EM QA training; no certifications required.
- Ability to support 24-hour/day operations; travel ~20%.
Benefits (as stated):
- Eligible for company bonus (for full-time equivalent employees) and comprehensive benefit program (e.g., 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).
- Serve as a liaison between contract manufacturing organizations (CMs) and Lilly; be initial point of contact for quality issues.
- Provide quality oversight of CMs; escalate quality issues to Lilly QA management.
- Assist with establishing/revising Quality Agreements; ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
- Provide oversight of Lilly/API EM Quality Plans.
- Coordinate and perform QA responsibilities for API shipments from suppliers and CMs.
- Prepare for regulatory inspections with CMs; provide on-site support.
- Participate on the Technical Review Board; evaluate/disposition API batches (if required).
- Ensure documented checks are completed (incl. Certificates of Testing/Environmental Monitoring where applicable) and that deviations/changes/batch documentation meet requirements before release.
- Provide quality support for API manufacturing (review deviations, change controls, countermeasures); assess impacts of investigations/changes and ensure retrievable records.
- Ensure processes remain in control; monitor external regulatory findings.
- Review/approve documents (procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, computerized system validations).
- Participate in APR, productivity projects, Joint Process (JPT), and Post Launch Optimization (PLOT) Teams.
Basic Requirements:
- Bachelor’s degree in a science-related field.
- 2+ years GMP manufacturing experience in API or pharma experience (finished product, QC/QA, or Engineering).
- Authorized to work in the U.S. full-time (no visa sponsorship).
Additional Preferences:
- Quality support for QC, knowledge of quality systems/regulatory requirements, pharma manufacturing knowledge, mentoring/coaching, root cause analysis, statistical skills, written/verbal communication, attention to detail, computer proficiency, interpersonal skills, ability to prioritize, and influence/manage relationships.
Other Information:
- Complete required API EM QA training; no certifications required.
- Ability to support 24-hour/day operations; travel ~20%.
Benefits (as stated):
- Eligible for company bonus (for full-time equivalent employees) and comprehensive benefit program (e.g., 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, well-being benefits).