Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company
4 months ago
On-site
Huntsville, AL
$156,000 - $228,800 USD yearly
Operations
Position Overview
- 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 quality/compliance systems, activities, and personnel. Maintains utilities and ensures raw materials and drug substances are produced and released per cGMP 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/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 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
- Statistical analysis and computer applications
- Strong interpersonal/communication/networking skills
- Ability to influence diverse teams and manage multiple priorities
- Demonstrated problem-solving and analytical thinking
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits incl. 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., EAP, fitness, clubs/activities).
- 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 quality/compliance systems, activities, and personnel. Maintains utilities and ensures raw materials and drug substances are produced and released per cGMP 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/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 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
- Statistical analysis and computer applications
- Strong interpersonal/communication/networking skills
- Ability to influence diverse teams and manage multiple priorities
- Demonstrated problem-solving and analytical thinking
Benefits (as stated)
- Eligibility for company bonus; comprehensive benefits incl. 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., EAP, fitness, clubs/activities).