Senior / Principal Associate QA API External Manufacturing

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

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance and death benefits

Well-being benefits

Job summary

Eli Lilly and Company in Indianapolis seeks a Senior / Principal Associate QA API External Manufacturing to ensure quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations and company standards. This role involves oversight and collaboration with external manufacturing partners.

The role requires a Bachelor’s degree in a scientific discipline and 5–8 years of QA/API experience, with travel up to 25%.

Qualifications

• Bachelor's degree in a scientific discipline (Chemistry/Pharmacy/Engineering) is required.
• 5+ years QA experience in pharma/biopharma with focus on APIs; 8 years for Principal role.
• Strong knowledge of cGMPs (FDA/EMA) and international standards.

Responsibilities

• Serve as QA contact for assigned API external sites and maintain partnerships.
• Review/approve master batch records, deviations, investigations, CAPAs, change controls, and OOS reports for cGMP compliance.
• Lead QA audits of external manufacturers to assess regulatory compliance and internal quality systems.
• Oversee approvals of quality events and ensure timely, effective resolutions.
• Collaborate with Supply Chain, Regulatory Affairs, and Technical Services on tech transfers and new product introductions.
• Monitor quality metrics at external manufacturers and drive corrective actions.
• Develop and maintain quality agreements with external partners.
• Support regulatory inspections and responses related to external manufacturing.
• Maintain knowledge of current cGMP regulations and industry best practices.

Skills

Quality Assurance

cGMP knowledge

Auditing

Regulatory compliance

Analytical testing

Communication skills

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.

• 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)

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