Principal QA, API, External Manufacturing, Peptides

Eli Lilly and Company

Quality Assurance oversight role for API External Manufacturing operations at Eli Lilly. Ensuring compliance with cGMP and regulatory requirements in pharmaceutical industry.

Posted 4/18/2026full-timeIndianapolis • North Carolina • 🇺🇸 United StatesLead💰 $65,250 - $169,400 per yearWebsite

About the role

Key responsibilities & impact

Lead and manage quality aspects of external API manufacturing sites, including but not limited to batch record review, disposition, deviation management, and change control
Conduct and/or participate in quality audits of external manufacturing sites to assess compliance with cGMP, regulatory expectations, and Eli Lilly's quality standards
Review and approve quality-related documents, such as manufacturing master batch records, validation protocols and reports, stability data, and analytical methods
Collaborate cross-functionally with internal teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) and external manufacturing partners to resolve quality issues and drive continuous improvement
Provide expert QA guidance and support during new product introductions and technology transfers to external manufacturers
Develop, implement, and maintain quality agreements with external manufacturing organizations
Investigate and troubleshoot complex quality incidents, deviations, and out-of-specification results, determining root causes and implementing effective corrective and preventive actions (CAPAs)
Represent Eli Lilly's quality interests during regulatory inspections at external manufacturing sites
Mentor and provide technical guidance to junior QA associates

Requirements

What you’ll need

Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Chemical Engineering or related scientific discipline
Minimum 5 years experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and external supply
Experience in cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements
Experience in auditing external manufacturing sites
Experience in quality management systems (e.g., Veeva)
Willingness to travel domestically and internationally to external manufacturing sites as required
Qualified applicants must be authorized to work in the United States on a full-time basis

Benefits

Comp & perks

Comprehensive benefit program including medical, dental, vision, and prescription drug benefits
Eligibility to participate in a company-sponsored 401(k)
Pension benefits
Vacation benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and death benefits
Certain time off and leave of absence benefits
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality assurancebatch record reviewdeviation managementchange controlquality auditsCAPAanalytical methodsquality agreementstroubleshootingroot cause analysis

Soft Skills

collaborationmentoringcommunicationproblem-solvingleadership