Senior Director, QA – GMP API Site Leader

Regulatory Jobs; Huntsville (AL); On-site; USD 156,000 - 229,000; Full time

Job summary

Lilly is currently constructing an advanced manufacturing facility for production of API molecules. The Sr. Director – QA will serve 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. The Sr. Director – QA leads the API Quality Team, drives QA strategy, coordinates regulatory inspections, and maintains

Qualifications

• Bachelor's degree in STEM field.
• 10+ years in pharmaceutical manufacturing quality.
• 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.

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.

Skills

Site QA leadership

cGMP compliance

Regulatory compliance

Quality systems

Leadership

Statistical analysis

Education

Bachelor's degree in STEM

Tools

Quality Management System (QMS)

Document control systems

Job description

Lilly is currently constructing an advanced manufacturing facility for production of API molecules. The Sr. Director – QA will serve 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. The Sr. Director – QA leads the API Quality Team, drives QA strategy, coordinates regulatory inspections, and maintains