Principal - QA API External Manufacturing Peptides
NCBiotech, Durham, NC, United States
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana.
Lilly, Inc. ("Lilly") develops and delivers life‑changing medicines for patients worldwide.
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 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 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 (Supply Chain, Regulatory Affairs, Technical Services) and external 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 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, focusing on API manufacturing and external supply.
Experience in cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
Experience auditing external manufacturing sites.
Experience in quality management systems (e.g., Veeva).
Willingness to travel domestically and internationally to external manufacturing sites as required.
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.
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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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 employees are also eligible for a company bonus and a comprehensive benefit program, including a 401(k) plan, pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits, life insurance, and well‑being benefits.
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Lilly, Inc. ("Lilly") develops and delivers life‑changing medicines for patients worldwide.
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 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 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 (Supply Chain, Regulatory Affairs, Technical Services) and external 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 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, focusing on API manufacturing and external supply.
Experience in cGMP regulations (FDA, EMA, HPRA, etc.) and global pharmacopeial requirements.
Experience auditing external manufacturing sites.
Experience in quality management systems (e.g., Veeva).
Willingness to travel domestically and internationally to external manufacturing sites as required.
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.
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.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
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 employees are also eligible for a company bonus and a comprehensive benefit program, including a 401(k) plan, pension, vacation benefits, medical, dental, vision and prescription drug benefits, flexible benefits, life insurance, and well‑being benefits.
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