Sr. Director - API Manufacturing Quality Assurance
Eli Lilly and Company
Full-time
Remote friendly (Lebanon, IN)
United States
$151,500 - $222,200 USD yearly
Operations
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Role Summary
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. Additionally, the Sr. Director – QA is responsible for maintaining utilities and ensuring that raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.
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.
Qualifications
- Bachelor's degree (STEM degree preferred)
- 10+ years of pharmaceutical manufacturing quality experience
- 5+ years of supervision/leadership experience
- 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
Skills
- Quality leadership
- Regulatory compliance and cGMP knowledge
- Quality systems management
- Training and performance coaching
- Strategic planning and metrics development
Education
- Bachelor's degree (STEM preferred)
Additional Requirements
- Location and travel as required for site operations and regulatory inspections.