Senior QA Lead, External API Manufacturing

Eli Lilly and Company; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Vacation benefits

Bonus potential

Job summary

Eli Lilly and Company in Indianapolis seeks a highly motivated Senior/Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured APIs under cGMP.

You will oversee external sites, review master batch and deviation records, participate in audits, support regulatory inspections, and partner with cross‑functional teams to enable smooth technology transfers and continuous improvement, with travel up to 25%.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering or related field.
• Minimum of 5 years (Senior) or 8 years (Principal) QA in pharma with API focus.
• In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7).
• Experience auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).
• Strong analytical, release criteria for APIs and good communication skills.
• English proficiency; travel up to 25%.

Responsibilities

• Serve as QA point of contact for assigned API external sites and manage partnerships.
• Review and approve master batch records, executed batch records, deviations, investigations, CAPAs, and change controls.
• Lead quality audits of external manufacturing partners for cGMP, regulatory and internal standards.
• Oversee and approve critical quality events, investigations, and CAPAs.
• Collaborate with Supply Chain, Regulatory Affairs, and Technical Services for technology transfers and improvements.
• Monitor quality metrics and identify trends with corrective actions.
• Develop and maintain quality agreements with external partners.
• Ensure APIs meet Lilly quality standards and regulatory requirements for release.
• Support regulatory inspections and respond to inquiries.
• Maintain current knowledge of cGMP regulations and industry best practices.

Skills

QA experience

External manufacturing

cGMP knowledge

Regulatory knowledge

Communication skills

Education

Bachelor's degree in Chemistry or Pharmacy or Chemical Engineering

Job description

Eli Lilly and Company in Indianapolis seeks a highly motivated Senior/Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured APIs under cGMP.

You will oversee external sites, review master batch and deviation records, participate in audits, support regulatory inspections, and partner with cross‑functional teams to enable smooth technology transfers and continuous improvement, with travel up to 25%.