Senior QA Lead, External API Manufacturing

Biopharma Careers; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical insurance

Dental insurance

Vision benefits

Flexible benefits

Life insurance

Wellbeing program

Job summary

Lilly in Indianapolis, Indiana, seeks a Senior / Principal Associate QA API External Manufacturing to ensure cGMP compliance and quality across externally manufactured APIs. You will serve as the QA contact for external sites and collaborate with cross-functional teams to support tech transfers and continuous improvement.

We require a strong background in API manufacturing, cGMPs, and audits, with excellent communication and the ability to travel up to 25%.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering (or related).
• Minimum 5 years (Senior) or 8 years (Principal) QA experience in pharma/biopharma with API focus.
• Strong knowledge of cGMP regulations (FDA/EMA) and ICH quality standards.
• Experience auditing external manufacturing sites and managing deviations, CAPAs, investigations.

Responsibilities

• Be the primary QA contact for assigned API external manufacturing sites.
• Review and approve manufacturing documentation to ensure cGMP compliance and quality.
• Lead quality audits of external manufacturing partners.
• Approve critical quality events and ensure timely resolutions.
• Collaborate with Supply Chain, Regulatory, and Tech Services for transfers and improvements.
• Monitor quality metrics and drive corrective actions.
• Develop and maintain quality agreements with external sites.
• Support regulatory inspections and provide responses as needed.

Skills

QA in pharma API

cGMP knowledge

Auditing external sites

Project management

Communication

Cross-functional collaboration

Travel willingness

Education

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering

Job description

Lilly in Indianapolis, Indiana, seeks a Senior / Principal Associate QA API External Manufacturing to ensure cGMP compliance and quality across externally manufactured APIs. You will serve as the QA contact for external sites and collaborate with cross-functional teams to support tech transfers and continuous improvement.

We require a strong background in API manufacturing, cGMPs, and audits, with excellent communication and the ability to travel up to 25%.