Principal QA, API, External Manufacturing, Peptides
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: Indianapolis • North Carolina • United States
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Salary
💰 $65,250 - $169,400 per year
Job Level
About the role
- 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
- 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
- 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)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurancebatch record reviewdeviation managementchange controlquality auditsCAPAanalytical methodsquality agreementstroubleshootingroot cause analysis
Soft Skills
collaborationmentoringcommunicationproblem-solvingleadership