Senior / Principal Associate QA API External Manufacturing

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

Job summary

Eli Lilly and Company is seeking a Senior/Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured APIs in line with cGMP regulations. The role involves significant oversight and collaboration with external manufacturing partners.

Responsibilities include reviewing documentation, leading audits, managing deviations and CAPAs, and supporting tech transfers and regulatory interactions. Travel up to 25% may be required.

Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related field.
• Minimum 5 years (Senior) or 8 years (Principal) QA experience in pharmaceutical/biopharmaceutical industry with focus on API manufacturing or external supply chain quality.
• In-depth knowledge of cGMP regulations and international quality standards applicable to API manufacturing.
• Experience auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).

Responsibilities

• Serve as QA contact for assigned API external manufacturing sites and foster collaboration.
• Review and approve manufacturing documentation to ensure cGMP compliance and product quality.
• Lead quality audits of external manufacturing partners to assess regulatory compliance.
• Oversee and approve critical quality events, investigations, and CAPAs with timely resolution.
• Collaborate with cross-functional teams to support tech transfers and continuous improvement at external sites.
• Monitor quality metrics and implement corrective actions for external manufacturers.
• Develop and maintain quality agreements with external partners.
• Support regulatory inspections and respond to inquiries related to external manufacturing.
• Maintain knowledge of cGMP regs (FDA/EMA) and industry best practices.

Skills

Quality Assurance

Auditing

cGMP knowledge

Regulatory liaison

Stakeholder collaboration

Education

Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or related

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.

Job Summary

Eli Lilly and Company is seeking a highly motivated and experienced Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role will involve significant oversight and collaboration with external manufacturing partners.

Job Responsibilities

• Serve as the primary Quality Assurance point of contact for assigned API external manufacturing sites, fostering strong collaborative relationships.
• Review and approve manufacturing documentation, including master batch records, executed batch records, deviations, investigations, CAPAs, change controls, and OOS reports, to ensure cGMP compliance and product quality.
• Participate in and lead quality audits of external manufacturing partners to assess compliance with cGMPs, regulatory requirements, and internal quality systems.
• Oversee and approve critical quality events, including significant deviations, investigations, and CAPAs, ensuring timely and effective resolution.
• Collaborate with internal cross-functional teams (e.g., Supply Chain, Regulatory Affairs, Technical Services) to support new product introductions, technology transfers, and continuous improvement initiatives at external manufacturing sites.
• Monitor key quality metrics and performance indicators for assigned external manufacturers, identifying trends and implementing corrective actions as needed.
• Contribute to the development, implementation, and maintenance of quality agreements with external manufacturing partners.
• Ensure all externally manufactured APIs meet Eli Lilly and Company's quality standards and regulatory requirements for release.
• Support regulatory inspections and provide responses to regulatory inquiries related to external manufacturing activities.
• Maintain current knowledge of cGMP regulations (e.g., FDA, EMA) and industry best practices relevant to API manufacturing and external supply chain quality.

Job Qualifications

• Bachelor's degree in Chemistry, Pharmacy, Chemical Engineering, or a related scientific discipline.
• Minimum of 5 years (Senior Associate) or 8 years (Principal Associate) of experience in Quality Assurance within the pharmaceutical or biopharmaceutical industry, with a strong focus on API manufacturing and/or external supply chain quality.
• In-depth knowledge of cGMP regulations (e.g., 21 CFR Part 210/211, ICH Q7) and international quality standards applicable to API manufacturing.
• Proven experience in auditing external manufacturing sites and managing quality events (deviations, investigations, CAPAs).
• Strong understanding of analytical testing methods, stability programs, and release criteria for APIs.
• Excellent communication, interpersonal, and negotiation skills, with the ability to effectively collaborate with diverse internal and external stakeholders.
• Demonstrated ability to work independently, prioritize tasks, and manage multiple projects simultaneously in a fast‑paced environment.
• Strong problem‑solving and decision‑making abilities with a keen attention to detail.
• Proficiency in English; additional language skills are a plus.
• Ability to travel domestically and internationally as required (up to 25%).

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form https://careers.lilly.com/us/en/workplace-accommodation for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and 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.

#WeAreLilly