Senior Director, API Quality & GMP Compliance

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

Benefits offered by this job

401(k) plan

Pension

Medical/dental/vision benefits

Well-being programs

Job summary

Lilly is constructing a new API manufacturing site and seeks a Sr. Director – QA to lead site quality, oversee manufacturing, utilities, labs and warehousing, and ensure products are released per cGMP standards and marketing authorization requirements.

The role requires strong leadership, regulatory experience, and a track record building and maturing QA programs in pharma manufacturing.

Qualifications

• Bachelor's degree in STEM required.
• 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 and regulatory commitments.
• Lead the API Quality Team and manage its agenda.
• Coordinate and manage regulatory inspections.
• Review and approve manufacturing and quality system documents.
• Provide coaching and development for QA staffing.
• Contribute to QA business and site-wide strategic planning.

Skills

Quality leadership

Regulatory compliance

Statistical analysis

People management

Education

Bachelor's degree in STEM

Job description

Lilly is constructing a new API manufacturing site and seeks a Sr. Director – QA to lead site quality, oversee manufacturing, utilities, labs and warehousing, and ensure products are released per cGMP standards and marketing authorization requirements.

The role requires strong leadership, regulatory experience, and a track record building and maturing QA programs in pharma manufacturing.