Backed by 500 Global.
About the role
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.
What they're looking for
- License to operate: Your strategy and leadership will drive FDA/EU/MHRA compliance, inspection outcomes, and the trust that underpins every batch we release
- Global influence, local execution: Operate at the intersection of site excellence and global harmonization—aligning site operations with enterprise QA standards across the US, UK, and Denmark
- People and performance: Build, mentor, and scale a high-performing QA organization, define KPIs and governance that elevate quality system maturity and accelerate continuous improvement
- 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
More about this role
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...
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