Principal - QA API External Manufacturing Peptides

Eli Lilly and Company • Us, IN

1d • Onsite

About The Position

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. 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.

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.

Nice To Haves

• 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.

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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical benefits
• dental benefits
• vision benefits
• prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal