Senior Director, Quality Assurance

Fujifilm•Research Triangle Park, NC

11d•Onsite

About The Position

Set the quality bar for a site that manufactures tomorrow’s therapies. As Senior Director, QA, you will sit on both the Site Leadership Team (SLT) and the Global QA Leadership Team—shaping site quality aspirations, executing the global QA strategy, and hardwiring inspection readiness into daily operations. You’ll lead Quality Operations, Quality Systems, Quality Training, and Supplier Qualification, ensuring harmonized, compliant Quality Systems that keep our license to operate strong and our clients confident. If you’re an executive QA leader who builds high-performing teams and delivers excellence in a 24/7 GMP environment, this is your moment to make a lasting impact. At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare. Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities. 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

Requirements

Master’s degree in Life Science, Pharmaceuticals, or a similar field with 13+ years of QA experience in the biopharmaceutical or biotech industry; OR Bachelor’s degree in Science, Engineering, Life Science, Pharmaceuticals, or a similar field with 15+ years of QA experience in the biopharmaceutical or biotech industry.
12+ years of people management, leadership, and team management experience.
Prior experience in a GMP environment working with FDA, EU, and MHRA regulations.
Must be flexible to support a 24/7 manufacturing facility.

Nice To Haves

Degree in Science, Engineering, or a similar field.
Lean Six Sigma or other certification.

Responsibilities

Define and execute the site QA strategy aligned with corporate goals and regulatory standards; ensure readiness for regulatory inspections and customer audits.
Lead and mentor a high-performing QA organization (Quality Operations, Quality Systems, Quality Training, Supplier Qualification), collaborating with the global QA function to ensure alignment and impact.
Guide the evolution of QA capabilities—ensuring the team has the technical depth and compliance systems to meet current and emerging regulatory requirements.
Oversee regulatory inspections and interactions; participate in customer visits and audits in collaboration with the Customer Quality function; ensure robust inspection management and follow-up.
Ensure sufficient resources and build high-trust relationships with partners; identify cost-saving opportunities while maintaining compliance and quality standards.
Champion site development and expansion through leadership aspirations; role model FUJIFILM Diosynth Biotechnologies (FDB) values.
Adhere to enterprise KPIs; establish actionable site-level KPIs and quality governance processes that drive continuous, effective improvements to quality systems locally and globally.
Build and maintain strong networks with internal site partners, global counterparts (US, Denmark, UK), external partners, and customers as needed.
Collaborate cross-functionally; provide leadership and guidance to assigned project teams to deliver quality outcomes on time.
Manage and develop direct reports within QA; conduct performance management and coaching to build future-ready talent.
Administer and enforce company policies (e.g., time off, shift work, inclement weather) and complete required administrative tasks (timecards, PTO approvals, expense reports).
Coach the team to foster professional development and long-term success; drive recruitment and retention strategies to attract and keep top talent.
Evaluate team performance; address gaps, questions, and concerns; partner with HR to resolve issues and implement measures that improve productivity and engagement.
Perform other duties as assigned.