About this opportunity
Regulatory Jobs lists this Principal - QA API External Manufacturing Peptides opportunity in indianapolis, Indiana. Review the employer’s description below for duties, qualifications and application requirements.
Job description
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Join the energetic and growing Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio of medicines essential to our patients around the world.
Job Summary
This role provides essential Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for all products manufactured by third-party partners.
Job Responsibilities
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.
Basic 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. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences
Strong understanding of API manufacturing processes, analytical techniques, and quality control principles.
Demonstrated ability to make sound quality decisions and effectively communicate complex technical and quality information to diverse audiences.
Excellent problem-solving, analytical, and critical thinking skills.
Ability to work independently and as part of a team in a fast-paced, dynamic environment.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly ( ), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
eligibility to participate in a company-sponsored 401(k)
pension
vacation benefits
eligibility for medical, dental, vision and prescription drug 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)
Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.