Senior QA Lead, External API Manufacturing

Regulatory Jobs; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Medical, dental, vision benefits

Well-being benefits

Job summary

Lilly is seeking a highly motivated Senior/Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured APIs under cGMP regulations and company standards. This role involves significant oversight of external manufacturing partners.

This position serves as the primary QA contact for API external sites, reviews documentation, leads audits, manages deviations and CAPAs, and collaborates with internal teams to support tech transfers and continuous

Qualifications

• Bachelor's degree in a relevant scientific discipline.
• 5 years (Senior) or 8 years (Principal) QA in pharma with APIs/external supply.
• Solid knowledge of cGMPs (FDA/EMA) and ICH guidelines.
• Auditing external manufacturing sites and handling quality events.
• Strong communication and stakeholder management.

Responsibilities

• Serve as the QA contact for assigned API external sites.
• Review and approve master/executed batch records and deviations.
• Lead quality audits of external manufacturing partners.
• Oversee and approve investigations and CAPAs.
• Collaborate with Supply Chain, Regulatory Affairs, and Tech Services.
• Monitor quality metrics and drive corrective actions.
• Develop and maintain quality agreements with partners.
• Ensure APIs meet Lilly quality standards for release.
• Support regulatory inspections and inquiries.
• Maintain knowledge of cGMP regulations and industry best practices.
• Travel domestically and internationally up to 25%.

Skills

QA

cGMP

Audits

Documentation review

Cross-functional collab

Regulatory knowledge

Education

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering or related

Job description

Lilly is seeking a highly motivated Senior/Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured APIs under cGMP regulations and company standards. This role involves significant oversight of external manufacturing partners.

This position serves as the primary QA contact for API external sites, reviews documentation, leads audits, manages deviations and CAPAs, and collaborates with internal teams to support tech transfers and continuous