Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company
August 24, 2026
On-site
Huntsville, AL
$156,000 - $228,800 USD yearly
Operations
Position Overview
The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. Ensures strength and continuous improvement of all quality and compliance systems, activities, and personnel. Maintains utilities and ensures raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.
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 pharmaceutical manufacturing quality experience
- 5+ years 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
Benefits (if applicable)
- Eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness benefits, employee clubs/activities)
Compensation
- Anticipated wage: $156,000 - $228,800
Application Instructions
- If you require accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation
The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. Ensures strength and continuous improvement of all quality and compliance systems, activities, and personnel. Maintains utilities and ensures raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.
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 pharmaceutical manufacturing quality experience
- 5+ years 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
Benefits (if applicable)
- Eligibility to participate in a company-sponsored 401(k); pension; vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance; certain time off/leave; well-being benefits (EAP, fitness benefits, employee clubs/activities)
Compensation
- Anticipated wage: $156,000 - $228,800
Application Instructions
- If you require accommodation to submit a resume, complete: https://careers.lilly.com/us/en/workplace-accommodation