Eli Lilly and Company
Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company, Houston, Texas, United States, 77246
Sr. Director - API Manufacturing Quality Assurance
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Sr. Director - API Manufacturing Quality Assurance
role at
Eli Lilly and Company At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is constructing an advanced manufacturing facility for production of API molecules, and this role is an opportunity to help build the organization, facility, and culture for a greenfield GMP manufacturing startup. Position Overview
The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel, and maintains utilities and raw material and drug substance production in accordance with cGMP standards. Key Responsibilities
Serve as Site Quality Leader on the Lilly Site Lead Team. Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. Lead the API Quality Team and manage its agenda. Support quality forums (e.g., Deviation and Change Control Boards). Develop and monitor a site Quality Plan and metrics. Coordinate and manage regulatory inspections. Review and approve manufacturing and quality system documents. Ensure adequate QA staffing and provide coaching and development. Use HR tools for performance management, staffing, and succession planning. Contribute to QA business planning and site-wide strategic planning. Basic Requirements
Bachelor’s degree (STEM degree preferred). 10+ years of pharmaceutical manufacturing quality experience. 5+ years of supervision/leadership experience. Additional Preferences
Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs. Proficient in statistical analysis and computer applications. Strong interpersonal, communication, and networking skills. Ability to influence diverse teams and manage multiple priorities. Demonstrated problem‑solving and analytical thinking. Equal Opportunity Employer
Lilly is proud to be an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of age, race, color, religion, gender identity or expression, sexual orientation, gender expression, gender identity, or any other legally protected status. Lilly is committed to providing accommodations to qualified individuals with disabilities.
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Join to apply for the
Sr. Director - API Manufacturing Quality Assurance
role at
Eli Lilly and Company At Lilly, we unite caring with discovery to make life better for people around the world. Lilly is constructing an advanced manufacturing facility for production of API molecules, and this role is an opportunity to help build the organization, facility, and culture for a greenfield GMP manufacturing startup. Position Overview
The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. This role ensures the strength and continuous improvement of all quality and compliance systems, activities, and personnel, and maintains utilities and raw material and drug substance production in accordance with cGMP standards. Key Responsibilities
Serve as Site Quality Leader on the Lilly Site Lead Team. Ensure site-wide compliance with cGMPs, procedures, standards, and regulatory commitments. Lead the API Quality Team and manage its agenda. Support quality forums (e.g., Deviation and Change Control Boards). Develop and monitor a site Quality Plan and metrics. Coordinate and manage regulatory inspections. Review and approve manufacturing and quality system documents. Ensure adequate QA staffing and provide coaching and development. Use HR tools for performance management, staffing, and succession planning. Contribute to QA business planning and site-wide strategic planning. Basic Requirements
Bachelor’s degree (STEM degree preferred). 10+ years of pharmaceutical manufacturing quality experience. 5+ years of supervision/leadership experience. Additional Preferences
Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs. Proficient in statistical analysis and computer applications. Strong interpersonal, communication, and networking skills. Ability to influence diverse teams and manage multiple priorities. Demonstrated problem‑solving and analytical thinking. Equal Opportunity Employer
Lilly is proud to be an Equal Employment Opportunity (EEO) employer and does not discriminate on the basis of age, race, color, religion, gender identity or expression, sexual orientation, gender expression, gender identity, or any other legally protected status. Lilly is committed to providing accommodations to qualified individuals with disabilities.
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