Senior Director, QA — Global Compliance & Readiness

FUJIFILM; North Carolina; On-site; USD 250,000 - 350,000; 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 align local activities with global QA standards. You will build a high-performing team, drive inspections, and partner with customers to uphold the highest quality.

This executive role demands strategic vision and strong regulatory acumen.

Qualifications

• 13+ years of QA experience in biopharma/biotech.

Responsibilities

• Define the QA strategy for the site aligned with regulatory standards.
• Lead and mentor the QA organization (Quality Operations, Systems, Training, Supplier Qualification).
• Ensure readiness for regulatory inspections and customer audits.
• Collaborate with global QA to maintain harmonized quality systems.
• Drive continuous improvement and governance across QA functions.
• Develop leaders and manage succession within QA teams.
• Oversee resource planning, budgeting, and relationships with partners.

Skills

Executive leadership

QA strategy

People management

Regulatory liaison

Strategic thinking

Education

Master’s degree in Life Science/Pharma

Bachelor’s degree in Science/Engineering/Life Science

Tools

Lean Six Sigma

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 align local activities with global QA standards. You will build a high-performing team, drive inspections, and partner with customers to uphold the highest quality.

This executive role demands strategic vision and strong regulatory acumen.