QA Associate Director, GMP Startup Leader

Biopharma Careers; Lebanon (KY); On-site; USD 123,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Job summary

Lilly is building a greenfield manufacturing site in Lebanon, IN, and seeks an Associate Director – QA to lead QA operations, ensure product quality, and drive regulatory compliance across API manufacturing and related facilities. The role focuses on coaching QA staff, maintaining quality systems, and coordinating with cross-functional teams to support startup and ongoing GMP operations.

The successful candidate will oversee QA performance, handle deviations and change controls, and ensure

Qualifications

• 5+ years in CGMP Manufacturing or equivalent.
• Experience supervising/leading people.
• Strong written and verbal communications skills.

Responsibilities

• Provide coaching/feedback to QA staff and develop team.
• Oversee quality oversight of API manufacturing, laboratories, and warehouses.
• Maintain and improve quality systems and procedures.
• Approve deviations, procedures, and change controls.
• Prepare teams for audits and regulatory inspections.
• Ensure on-time completion of internal and external quality commitments.

Skills

Leadership

Quality systems

CGMP knowledge

Communications

Process improvement

Analytical thinking

Attention to detail

Education

BS or equivalent in a scientific field or engineering

Job description

Lilly is building a greenfield manufacturing site in Lebanon, IN, and seeks an Associate Director – QA to lead QA operations, ensure product quality, and drive regulatory compliance across API manufacturing and related facilities. The role focuses on coaching QA staff, maintaining quality systems, and coordinating with cross-functional teams to support startup and ongoing GMP operations.

The successful candidate will oversee QA performance, handle deviations and change controls, and ensure