Backed by 500 Global.
About the role
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. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Demonstrated ability to efficiently execute audits and inspections, communicate with external parties and health authorities, and build trust with inspectors
- 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
More about this role
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.
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...
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