Sr. Director - API Manufacturing Quality Assurance

Lilly • Huntsville, AL

1d • $163,500 - $239,800

About The Position

Lilly is constructing an advanced manufacturing facility for API molecules to supply current and future products, including new modalities. The role offers the opportunity to join the leadership team launching a greenfield manufacturing site and help build the organization, facility, and culture for startup into GMP manufacturing operations.

The Sr. Director – QA serves as the Site Quality Leader for the Lilly API site, overseeing manufacturing, utilities, laboratories, and warehousing. The role ensures the strength and continuous improvement of quality and compliance systems, activities, and personnel. It is also responsible for maintaining utilities and ensuring raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.

Requirements

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

Nice To Haves

• STEM degree preferred.
• Experience in Manufacturing, Development, QC, Technical Services, Engineering, or Regulatory Affairs.
• Proficiency 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, including 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.
• Oversee manufacturing, utilities, laboratories, and warehousing.
• Maintain utilities and ensure raw materials and drug substances are produced and released in accordance with cGMP standards and marketing authorization requirements.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior