Backed by 500 Global.
About the role
Shape our Quality Control strategy and culture at a growth-oriented site in College Station, Texas as our Senior Director of Quality Control. Lead our site QC organization and shape the analytical strategy that enables right-first-time data, timely disposition, and sustained regulatory compliance.
What they're looking for
- Strategy, governance, and compliance
- Establish and review KPIs (e.g., OTIF, OOS/OOT, lead time, right-first-time, deviation/invalid rates, CAPA effectiveness) to drive performance and compliance
- Ensure phase-appropriate policies, standards, and procedures aligned with FDA, EMA, ICH, USP/EP, and corporate requirements
- Own inspection readiness, lead regulatory/client audits and deliver timely, effective responses and commitments
- Own the QC operating and capital budgets, forecast resources, headcount, and instruments
- Operational excellence and method lifecycle
More about this role
Shape our Quality Control strategy and culture at a growth-oriented site in College Station, Texas as our Senior Director of Quality Control. Lead our site QC organization and shape the analytical strategy that enables right-first-time data, timely disposition, and sustained regulatory compliance. This executive leader will operate within the global quality leadership network, while setting the QC vision and roadmap, develop high-performing teams across analytical, microbiology, and environmental monitoring, and elevate performance through governance, digital systems, and continuous improvement in Texas.
The work we do at FUJIFILM Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives.
From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.
If you’re ready to help transform the future of medicine, join FUJIFILM Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what...
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