API Quality Leader — Startup Site Director

100 Eli Lilly and Company; Huntsville (AL); On-site; USD 156,000 - 229,000; Full time

Job summary

Lilly in Huntsville, AL seeks a Sr. Director – QA to lead the site quality function across manufacturing, utilities, laboratories and warehousing, ensuring robust quality and compliance systems and alignment with cGMP and regulatory requirements.

This leadership role oversees the QA team, regulatory inspections, and quality planning, while guiding coaching, staffing, and strategic QA initiatives to enable a successful startup and ongoing operations.

Qualifications

• Bachelor's degree (STEM degree preferred)
• 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

Leadership

QA

cGMP

Regulatory

Statistical analysis

Communication

Education

Bachelor's degree in STEM

Job description

Lilly in Huntsville, AL seeks a Sr. Director – QA to lead the site quality function across manufacturing, utilities, laboratories and warehousing, ensuring robust quality and compliance systems and alignment with cGMP and regulatory requirements.

This leadership role oversees the QA team, regulatory inspections, and quality planning, while guiding coaching, staffing, and strategic QA initiatives to enable a successful startup and ongoing operations.