Principal - QA API External Manufacturing Peptides
Eli Lilly and Company
5 hours ago
On-site
Indianapolis, IN
Operations
Job Summary
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for products manufactured by third-party partners.
Job Responsibilities
- Lead and manage quality aspects of external API manufacturing sites (e.g., batch record review, disposition, deviation management, change control).
- Conduct and/or participate in quality audits of external manufacturing sites for cGMP, regulatory, and company quality compliance.
- Review and approve quality-related documents (e.g., manufacturing master batch records, validation protocols/reports, stability data, analytical methods).
- Collaborate with internal teams (Supply Chain, Regulatory Affairs, Technical Services) and external partners to resolve quality issues and drive continuous improvement.
- Provide QA guidance/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; determine root causes and implement effective CAPAs.
- Represent company 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 Quality Assurance experience in pharmaceutical/biopharmaceutical industry focused 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.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work independently and in a fast-paced team environment.
Benefits (if applicable)
- Company bonus (for full-time equivalent employees, depending on company/individual performance).
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- Not specified in the provided text.
- Provide Quality Assurance oversight for API External Manufacturing operations, ensuring compliance with cGMP and regulatory requirements for products manufactured by third-party partners.
Job Responsibilities
- Lead and manage quality aspects of external API manufacturing sites (e.g., batch record review, disposition, deviation management, change control).
- Conduct and/or participate in quality audits of external manufacturing sites for cGMP, regulatory, and company quality compliance.
- Review and approve quality-related documents (e.g., manufacturing master batch records, validation protocols/reports, stability data, analytical methods).
- Collaborate with internal teams (Supply Chain, Regulatory Affairs, Technical Services) and external partners to resolve quality issues and drive continuous improvement.
- Provide QA guidance/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; determine root causes and implement effective CAPAs.
- Represent company 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 Quality Assurance experience in pharmaceutical/biopharmaceutical industry focused 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.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work independently and in a fast-paced team environment.
Benefits (if applicable)
- Company bonus (for full-time equivalent employees, depending on company/individual performance).
- Comprehensive benefits: 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- Not specified in the provided text.