Principal - QA API External Manufacturing Peptides
Eli Lilly and Company
August 24, 2026
On-site
Indianapolis, IN
Operations
Job Summary
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for products manufactured by third-party partners.
Responsibilities
- Lead/manage quality for external API manufacturing sites (batch record review, batch disposition, deviation management, change control).
- Conduct and/or participate in quality audits of external manufacturing sites for cGMP, regulatory expectations, and quality standards.
- Review/approve quality documents (manufacturing master batch records, validation protocols/reports, stability data, analytical methods).
- Collaborate cross-functionally and with external partners to resolve quality issues and drive continuous improvement.
- Provide QA guidance for new product introductions and technology transfers.
- Develop/maintain quality agreements with external manufacturers.
- Investigate complex quality incidents/deviations/OOS results; determine root cause and implement CAPAs.
- Represent QA during regulatory inspections at external sites.
- Mentor junior QA associates.
Basic Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related field.
- 5+ years QA experience in pharma/biopharma, focused on API manufacturing/external supply.
- cGMP experience (FDA/EMA/HPRA) and global pharmacopeial requirements.
- Experience auditing external manufacturing sites.
- Experience with quality management systems (e.g., Veeva).
- Ability to travel domestically/internationally.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas).
Additional Preferences
- Strong API manufacturing/analytical/quality control knowledge; sound quality decision-making and communication; problem-solving.
Benefits/Compensation (as stated)
- Anticipated wage: $65,250–$169,400; bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being).
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for products manufactured by third-party partners.
Responsibilities
- Lead/manage quality for external API manufacturing sites (batch record review, batch disposition, deviation management, change control).
- Conduct and/or participate in quality audits of external manufacturing sites for cGMP, regulatory expectations, and quality standards.
- Review/approve quality documents (manufacturing master batch records, validation protocols/reports, stability data, analytical methods).
- Collaborate cross-functionally and with external partners to resolve quality issues and drive continuous improvement.
- Provide QA guidance for new product introductions and technology transfers.
- Develop/maintain quality agreements with external manufacturers.
- Investigate complex quality incidents/deviations/OOS results; determine root cause and implement CAPAs.
- Represent QA during regulatory inspections at external sites.
- Mentor junior QA associates.
Basic Requirements
- Bachelor’s degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering, or related field.
- 5+ years QA experience in pharma/biopharma, focused on API manufacturing/external supply.
- cGMP experience (FDA/EMA/HPRA) and global pharmacopeial requirements.
- Experience auditing external manufacturing sites.
- Experience with quality management systems (e.g., Veeva).
- Ability to travel domestically/internationally.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas).
Additional Preferences
- Strong API manufacturing/analytical/quality control knowledge; sound quality decision-making and communication; problem-solving.
Benefits/Compensation (as stated)
- Anticipated wage: $65,250–$169,400; bonus eligibility and comprehensive benefits (e.g., 401(k), medical/dental/vision, life insurance, time off, well-being).