Senior Director, API Quality & Manufacturing

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

Benefits offered by this job

Company bonus

Comprehensive benefits

Job summary

Lilly is constructing an API manufacturing site and seeks a Sr. Director – QA to serve as the Site Quality Leader. The role oversees manufacturing, utilities, laboratories, and warehousing, ensuring quality and compliance across systems and staff.

You will guide regulatory readiness and drive improvements aligned with cGMP and marketing authorization requirements. The position emphasizes building a capable QA organization, staffing, coaching, and strategic QA planning.

Qualifications

• 10+ years of pharmaceutical manufacturing quality experience.
• 5+ years of supervision/leadership experience.

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

Quality leadership

Regulatory compliance

GMP knowledge

Education

Bachelor's degree (STEM degree preferred)

Tools

Statistical analysis

Computer applications

Job description

Lilly is constructing an API manufacturing site and seeks a Sr. Director – QA to serve as the Site Quality Leader. The role oversees manufacturing, utilities, laboratories, and warehousing, ensuring quality and compliance across systems and staff.

You will guide regulatory readiness and drive improvements aligned with cGMP and marketing authorization requirements. The position emphasizes building a capable QA organization, staffing, coaching, and strategic QA planning.