Principal - QA API External Manufacturing Peptides

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision

Flexible benefits

Life insurance

Well-being programs

Job summary

Lilly in Indianapolis is seeking an experienced Quality Assurance professional to oversee external API manufacturing, ensuring compliance with cGMP and regulatory requirements for products produced by third-party partners.

You will review master batch records, validation data, and stability information, and collaborate across functions to resolve quality issues, lead audits, and guide CAPA programs. Travel to external sites may be required.

Qualifications

• Bachelor's degree in a related scientific field.
• Minimum 5 years of QA experience in pharma with API external supply.
• Experience with cGMP regulations and auditing external sites.
• Experience with quality management systems (e.g., Veeva).

Responsibilities

• Oversee quality aspects of external API manufacturing sites, including batch record review, disposition, deviations, and change control.
• Conduct and/or participate in quality audits of external sites to assess cGMP compliance and QA standards.
• Review and approve quality documents (batch records, validation protocols, reports, stability data).
• Collaborate with internal functions and external partners to resolve quality issues and drive improvements.
• Provide QA guidance during tech transfers and new product introductions.
• Develop and maintain quality agreements with external manufacturers.
• Investigate quality incidents and drive CAPAs.
• Represent Lilly's QA interests during regulatory inspections at external sites.
• Mentor junior QA staff.

Skills

Quality Assurance

cGMP knowledge

External manufacturing audits

Quality systems (Veeva)

Education

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

Tools

Veeva

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 (BE@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.