Director, Quality Systems & Compliance — Inspection Readiness

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Director of Quality Systems and Compliance to lead PQS, audits, and regulatory readiness. You will drive continuous improvement, data integrity, and a strong quality culture across site operations, partnering with global teams and customers to ensure inspection readiness and compliant performance.

The role demands strategic leadership, deep cGMP knowledge, and proven ability to manage complex regulatory interactions, CAPAs, and

Qualifications

• Bachelor’s degree in Engineering or Life Science with 10+ years of related experience; or a Master’s degree with 8+ years.
• 6+ years of people management, leadership, and team management experience.
• Experience in cGMP manufacturing operations and FDA/EMA regulated facilities.
• Experience leading regulatory inspections and pre-approval inspections.
• Experience with regulatory inspections from multiple global health authorities.
• Experience with TrackWise and Veeva.

Responsibilities

• Leads development and oversight of PQS; ensures GMP/GDP compliance.
• Drives inspection readiness and manages responses to findings.
• Leads CAPAs, audits, remediation and continuous improvement.
• Partners with HR and leadership to develop talent and manage performance.
• Represents site in global forums and coordinates with clients.
• Ensures data integrity and quality culture across operations.
• Manages budgeting and administrative tasks.

Skills

Leadership

Regulatory knowledge

Quality mindset

Risk 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, seeks a Director of Quality Systems and Compliance to lead PQS, audits, and regulatory readiness. You will drive continuous improvement, data integrity, and a strong quality culture across site operations, partnering with global teams and customers to ensure inspection readiness and compliant performance.

The role demands strategic leadership, deep cGMP knowledge, and proven ability to manage complex regulatory interactions, CAPAs, and