Associate - QA API External Manufacturing Peptides

Role 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.

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.

Qualifications

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmacy, Chemical Engineering) or related field.
• Minimum of 5-8 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 external supply.
• In-depth knowledge of cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
• Proven experience in auditing external manufacturing sites.
• 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.
• Proficiency in quality management systems (e.g., TrackWise, Veeva).
• Willingness to travel domestically and internationally to external manufacturing sites as required.

Education

• Bachelor's degree in a scientific discipline (e.g., Chemistry, Biochemistry, Pharmacy, Chemical Engineering) or related field.

Additional Requirements

• Willingness to travel domestically and internationally to external manufacturing sites as required.