Principal - QA API External Manufacturing Peptides
Eli Lilly and Company
4 hours ago
On-site
Durham, NC
Operations
Job Summary:
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for third-party manufactured products.
Job Responsibilities:
- Lead and manage quality aspects of external API manufacturing sites, including 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 quality standards.
- Review and approve quality-related documents (e.g., manufacturing master batch records, validation protocols/reports, stability data, and analytical methods).
- Collaborate with internal teams (Supply Chain, Regulatory Affairs, Technical Services) and external partners to resolve quality issues and drive continuous improvement.
- Provide expert QA guidance during new product introductions and technology transfers to external manufacturers.
- Develop, implement, and maintain quality agreements with external manufacturing organizations.
- Investigate and troubleshoot quality incidents, deviations, and out-of-specification results; determine root causes and implement CAPAs.
- Represent 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 QA experience in pharmaceutical/biopharmaceutical industry with focus on API manufacturing and external supply.
- Experience with cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
- Experience auditing external manufacturing sites.
- Experience with quality management systems (e.g., Veeva).
- Willingness to travel domestically and internationally as required.
Additional Preferences:
- Strong understanding of API manufacturing processes, analytical techniques, and quality control principles.
- Ability to make sound quality decisions and communicate complex technical/quality information to diverse audiences.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work independently and in a team in a fast-paced environment.
Benefits (as stated):
- Company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance; certain time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for third-party manufactured products.
Job Responsibilities:
- Lead and manage quality aspects of external API manufacturing sites, including 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 quality standards.
- Review and approve quality-related documents (e.g., manufacturing master batch records, validation protocols/reports, stability data, and analytical methods).
- Collaborate with internal teams (Supply Chain, Regulatory Affairs, Technical Services) and external partners to resolve quality issues and drive continuous improvement.
- Provide expert QA guidance during new product introductions and technology transfers to external manufacturers.
- Develop, implement, and maintain quality agreements with external manufacturing organizations.
- Investigate and troubleshoot quality incidents, deviations, and out-of-specification results; determine root causes and implement CAPAs.
- Represent 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 QA experience in pharmaceutical/biopharmaceutical industry with focus on API manufacturing and external supply.
- Experience with cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
- Experience auditing external manufacturing sites.
- Experience with quality management systems (e.g., Veeva).
- Willingness to travel domestically and internationally as required.
Additional Preferences:
- Strong understanding of API manufacturing processes, analytical techniques, and quality control principles.
- Ability to make sound quality decisions and communicate complex technical/quality information to diverse audiences.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work independently and in a team in a fast-paced environment.
Benefits (as stated):
- Company-sponsored 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., healthcare and/or dependent day care FSA); life insurance; certain time off/leave of absence benefits; well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).