Director, Quality Systems & Compliance – Inspection Readiness

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Director of Quality Systems and Compliance to provide strategic leadership for PQS, audits, documentation, and GxP learning. You will drive inspection readiness, partner across functions, and strengthen data integrity and quality culture at the site.

The role requires extensive experience in GMP/QA, regulatory affairs, and leadership, with travel up to 20% across domestic and international sites as needed.

Qualifications

• Bachelor’s or Master’s degree in Engineering or Life Science with required years
• 10+ years of related experience for Bachelor’s degree or 8+ years with Master’s
• 6+ years of people management, leadership, and team management experience
• Experience working in cGMP manufacturing operations and/or Quality role in FDA/EMA regulated facility
• Experience with regulatory inspections from multiple global health authorities
• Experience leading pre-approval inspections (PAIs) and establishing quality metrics

Responsibilities

• Provide strategic leadership for Quality Systems, PQS, Audits, and Compliance programs
• Drive inspection readiness and lead regulatory inspections and customer audits
• Develop and oversee CAPAs, remediation plans, and audit responses
• Mentor and develop high-performing teams and drive productivity
• Partner with HR and cross-functional teams for talent management and program delivery
• Represent the site in global forums to align local with global quality strategies

Skills

Leadership

Regulatory inspections

Quality systems

Data integrity

Risk management

Cross-functional collaboration

Change management

Education

Bachelor’s degree in Engineering or Life Science

Master’s degree in Engineering or Life Science

Tools

TrackWise

Veeva

Job description

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking a Director of Quality Systems and Compliance to provide strategic leadership for PQS, audits, documentation, and GxP learning. You will drive inspection readiness, partner across functions, and strengthen data integrity and quality culture at the site.

The role requires extensive experience in GMP/QA, regulatory affairs, and leadership, with travel up to 20% across domestic and international sites as needed.