Director, Quality Systems & Compliance

** Position Overview*
* The Director, Quality Systems and Compliance provides strategic leadership for the site's Pharmaceutical Quality System (PQS), Audits and Inspections, Documentation Management, GxP Learning, and Quality Compliance programs. The role ensures sustainable inspection readiness, maintains compliance with global regulatory requirements, and drives continuous improvement across quality systems. The Director serves as a key site leader during customer audits and regulatory inspections and partners across functions to strengthen quality culture, data integrity, and operational excellence.

The Director, Quality Systems and Compliance fosters a strong Quality Culture across teams and contributes to cohesive implementation of quality systems at the Holly Springs site, aligning with organizational goals and regulatory expectations.

** Company Overview*
* FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we'll open North America's largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We're looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we're proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

** Job Description*
* ** What You'll Do*
* + Develops strategic plans for Quality Systems and support team, sets measurable goals, and oversees the supervision, development, and performance of team to foster long-term growth and a high-performing team environment.

+ Ensures and oversees the adherence, maintenance, and continuous improvement of PQS to confirm alignment with current GMP, GDP, and regulatory requirements through effective implementation of global policies while meeting local operational needs.

+ Owns the site Inspection Readiness Program; builds and ensures sustainable readiness through risk-based oversight of PQS subsystems, management reviews, metrics, and escalation processes.

+ Drives inspection readiness, ensuring adherence to global health regulations; leads end-to-end regulatory inspections and customer audits; guides response strategies and authors/reviews formal responses to inspectional observations, as applicable.

+ Ensures GxP compliance through robust quality systems, regulatory intelligence assessment, risk management, continuous improvement, and driving a proactive quality culture.

+ Develops and oversees robust corrective and preventive actions (CAPAs), remediation plans, and audit finding responses to prevent recurrence for both local and global site related commitments; verifies effectiveness through metrics and periodic reviews.

+ Ensures timely availability of site quality performance data, including metrics for quarterly management reviews, to identify emerging regulatory trends and monitor performance against agreed targets for driving improvements and achieving quality objectives.

+ Identifies and leads Quality Systems process improvement initiatives to enhance efficiency while maintaining compliance, ensuring alignment with industry best practices and regulatory expectations.

+ Partners with clients and internal stakeholders across functions to support Quality initiatives and innovation projects; collaborates cross function to ensure seamless integration of Quality Systems into broader operational goals.

+ Represents the site in global forums to align local practices with global strategies and share best practices.

+ Drives team efforts in curating critical knowledge to drive and develop best practices in Quality and Operational disciplines.

+ Mentors and motivates employees; evaluates team performance regularly; implements measures to improve productivity and engagement levels; identifies high-potential employees for further development opportunities.

+ Administers company policies such as time off, shift work, and inclement weather that directly impact employees.

+ Completes required administrative tasks (e.g., timecard approvals, time off approvals, expense reports etc.).

+ Participates in the recruitment process and retention strategies to attract and retain talent, as needed.

+ Addresses performance gaps, employee questions and concerns, and partners with HR as needed for resolution.

+ Performs other duties, as assigned.

** Knowledge, Skills, and Abilities*
* + Collaborative attitude…