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: https://www.fujifilm.com/us/en/about/region/careers

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 with the willingness to work with global peers and cross-functional teams to drive company/department level change and efforts for strengthening compliance, Quality mindset, and operational excellence initiatives.
• Strong analytical, problem-solving, organizational, and risk-based decision-making skills, with attention to detail and a solution-oriented mindset; ability to manage multiple priorities in a fast-paced, highly interactive environment.
• Demonstrated ability to efficiently execute audits and inspections, communicate with external parties and health authorities, and build trust with inspectors.
• Strong understanding of 21 CFR (Parts 210/211, 600/610, 11), EU GMP (EudraLex Vol 4, Annexes incl. Annex 1), ICH (Q7–Q10/Q12), GDP, GLP, GCP (ICH E6/E8), and medical devices/IVDs (21 CFR 820 (QMSR), EU MDR/IVDR, ISO 13485, ISO 14971, ISO 9001).
• Advanced knowledge of Data Integrity and ALCOA+ principles.
• Ability to influence at all levels, including senior leadership, and provide feedback in adherence with company values.
• Exceptional written and verbal communication skills, with the ability to remain calm and credible under pressure, adapt to differing audiences, advise on difficult matters, and present complex information effectively.
• Strong team leadership; demonstrated ability to hire, motivate, and develop top technical talent to build and lead a high performing team, projects, and programs while directing allocation of resources.
• Willingness to travel domestically and internationally, up to 20%; flexible to support a 24/7 manufacturing facility.

 Minimum Qualifications

• Bachelor’s degree in Engineering or Life Science with 10+ years of related experience; OR,
• Master’s degree in Engineering or Life Science with 8+ years of related experience.
• 6+ years of people management, leadership, and team management experience.
• 2+ years of experience leading and developing leaders (managers/supervisors).
• Experience working in a changing, project driven organization.
• Experience in cGMP manufacturing operations and/or Quality role in an FDA/EMA regulated facility.
• Experience with ICH Q7, 21 CFR part 820 and part 11, EU GMP vol 4, and ALCOA+ guidelines.
• Experience collaborating and interacting with a global team.
• Experience with regulatory inspections from multiple global health authorities.
• Experience managing complex global regulatory interactions.
• Experience leading pre-approval inspections (PAIs).
• Experience establishing quality metrics and performance.

 Preferred Qualifications

• Experience working in a GMP environment.
• 10+ years of experience in a GMP quality assurance (QA) or Regulatory Affairs role in a commercial biopharmaceutical facility.
• Experience from other GMP functions (manufacturing, MSAT, engineering).
• Strong track record of driving operational excellence.
• Experience with TrackWise and Veeva.

 Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.  While performing the duties of this job, the employee is required on a regular basis to:

• Ability to discern audible cues.
• Ability to stand for prolonged periods of time for up to 120 minutes.
• Ability to sit for prolonged periods of time for up to 120 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

*LI-Onsit

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([email protected]).