Executive QA Leader, 24/7 GMP Site

Merck & Co.; North Carolina; On-site; USD 250,000 - 320,000; Full time

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Senior Director, QA to set the quality bar for a 24/7 GMP site, lead Quality Operations, Systems, Training and Supplier Qualification, and drive global QA strategy with inspection readiness baked into daily operations.

You will build high-performing teams, align site operations with enterprise QA standards, and partner across US, UK, and Denmark to deliver world-class quality and compliance.

Qualifications

• Master's degree in Life Science, Pharmaceuticals, or similar with 13+ QA years or Bachelor's with 15+ QA years.
• 12+ years of people management and leadership experience.
• Experience in GMP with FDA/EU/MHRA regulations.

Responsibilities

• Define and execute the site QA strategy aligned with regulatory standards; ensure inspection readiness.
• Lead and mentor a high-performing QA organization across Quality Operations, Systems, Training, and Supplier Qualification.
• Oversee regulatory inspections and interactions; maintain robust inspection management and follow-up.
• Coach and develop team members; manage resources and recruitment to build future-ready talent.

Skills

QA Leadership

Regulatory Compliance

GMP

Auditing

People Management

Education

Master's in Life Sciences

Bachelor's in Science/Engineering

Job description

FUJIFILM Biotechnologies in North Carolina seeks a Senior Director, QA to set the quality bar for a 24/7 GMP site, lead Quality Operations, Systems, Training and Supplier Qualification, and drive global QA strategy with inspection readiness baked into daily operations.

You will build high-performing teams, align site operations with enterprise QA standards, and partner across US, UK, and Denmark to deliver world-class quality and compliance.