Global QA Executive: Inspection-Ready Quality Leader

FUJIFILM Biotechnologies; Durham (NC); On-site; USD 200,000 - 320,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a Senior Director, QA to join our North Carolina site, sitting on SLT and Global QA Leadership Team. You will shape site quality goals, lead Quality Operations, Systems, Training and Supplier Qualification, ensure readiness for regulatory inspections, and drive harmonized quality systems in a 24/7 GMP environment.

In this executive role, you’ll develop high-performing teams, define KPIs, and partner across US/UK/Denmark to align enterprise standards while

Qualifications

• Master’s degree in Life Science or related field with 13+ QA years.
• Or Bachelor’s degree with 15+ QA years.
• 12+ years of people management experience; GMP regulation experience (FDA/EU/MHRA).

Responsibilities

• Define and execute site QA strategy aligned with regulatory standards for inspections.
• Lead QA org (Operations, Systems, Training, Supplier Qualification) with global alignment.
• Oversee regulatory inspections and customer audits; ensure robust inspection management.

Job description

FUJIFILM Biotechnologies seeks a Senior Director, QA to join our North Carolina site, sitting on SLT and Global QA Leadership Team. You will shape site quality goals, lead Quality Operations, Systems, Training and Supplier Qualification, ensure readiness for regulatory inspections, and drive harmonized quality systems in a 24/7 GMP environment.

In this executive role, you’ll develop high-performing teams, define KPIs, and partner across US/UK/Denmark to align enterprise standards while