Sr. Director - API Manufacturing Quality Assurance

About This Role

Serve as the Site Quality Leader overseeing manufacturing, utilities, laboratories, and warehousing for a new API manufacturing facility. Ensure compliance with cGMPs, procedures, standards, and regulatory commitments, and lead the API Quality Team.

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

Requirements

• Bachelor's degree
• 10+ years of pharmaceutical manufacturing quality experience
• 5+ years of supervision/leadership experience

Qualifications

• Bachelor's degree (STEM degree preferred)
• 10+ years of pharmaceutical manufacturing quality experience, 5+ years of supervision/leadership experience

Nice to Have

• 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