Senior QA Lead, API External Manufacturing – Peptides

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

Job summary

Lilly is seeking an experienced Quality Assurance professional to oversee API External Manufacturing operations, ensuring cGMP compliance and regulatory alignment for products made by third-party partners.

You will lead batch review, deviations, audits, and CAPA programs, collaborating with Supply Chain, Regulatory, and Technical teams while mentoring junior staff. This on-site Indianapolis role emphasizes hands-on QA leadership.

Qualifications

• Bachelor's degree in a related scientific discipline.
• Minimum 5 years of QA experience in pharmaceutical/biopharma with API manufacturing/external supply.
• Experience with cGMP regulations (FDA/EMA/HPRA).
• Experience auditing external manufacturing sites.
• Willingness to travel domestically and internationally.
• Authorized to work in the United States full-time; no visa sponsorship provided.

Responsibilities

• Lead and manage quality aspects of external API manufacturing sites, including batch record review, disposition, deviation management, and change control.
• Conduct and/or participate in quality audits of external manufacturing sites to assess cGMP compliance and regulatory expectations.
• Review and approve quality-related documents such as master batch records, validation protocols and reports, stability data, and analytical methods.
• Collaborate cross-functionally with internal teams and external manufacturers to resolve quality issues and drive improvements.
• Provide QA guidance during new product introductions and technology transfers to external manufacturers.
• Develop, implement, and maintain quality agreements with external manufacturing organizations.
• Investigate and troubleshoot quality incidents, deviations, and OOS results, determining root causes and CAPAs.
• Represent Lilly's quality interests during regulatory inspections at external manufacturing sites.
• Mentor and provide technical guidance to junior QA associates.

Skills

Quality Assurance experience

cGMP regulations

Auditing external sites

Quality management systems (Veeva)

Travel willingness

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmacy/Chemical Engineering

Tools

Veeva

Job description

Lilly is seeking an experienced Quality Assurance professional to oversee API External Manufacturing operations, ensuring cGMP compliance and regulatory alignment for products made by third-party partners.

You will lead batch review, deviations, audits, and CAPA programs, collaborating with Supply Chain, Regulatory, and Technical teams while mentoring junior staff. This on-site Indianapolis role emphasizes hands-on QA leadership.