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. This on-site role may be based at either the Indianapolis, IN or Durham, NC sites.
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.
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.
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