Director, Quality Systems & Compliance

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

Job summary

FUJIFILM Biotechnologies in the United States seeks a Director of Quality Systems and Compliance to lead site PQS, audits, and regulatory readiness at the Holly Springs facility. This role partners across functions to strengthen data integrity, quality culture, and operational excellence while guiding responses to inspections.

The role requires extensive cGMP knowledge, strategic leadership, and global regulatory exposure, with travel up to 20% as needed to support inspections and intercompany

Qualifications

• Bachelor's degree in Engineering or Life Science with 10+ years of related experience.
• 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.

Responsibilities

• 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.

Skills

Quality leadership

Regulatory knowledge

GxP compliance

Audits & inspections

Data integrity

Risk management

Team leadership

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Science

Master's degree in Engineering or Life Science

Job description

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.

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.