Senior Director, Quality Control

Position Overview

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 we call Genki.

Our state-of-the‑art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top‑notch schools, and close proximity to big city life. Nestled between major hubs, it's a dynamic location that blends convenience with innovation.

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:

You will align site priorities to global strategy and partner closely with clients and regulators. You will lead complex, impactful biologics programs and enable timely, compliant product disposition. As Senior Director, you will build the digital, technical and organizational capabilities to make an impact to patients around the world.

• Strategy, governance, and compliance
  • Set and execute the site QC strategy and roadmap aligned to Global QC.
  • 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
  • Oversee all QC operations, including in‑process, release, stability, microbiology, and environmental/utility monitoring to meet program timelines and specifications.
  • Ensure implementation, qualification, and maintenance of laboratory systems/equipment; maintain system suitability, calibration, and preventive maintenance programs.
  • Drive continuous improvement in workflows, scheduling, electronic documentation, and data integrity to reduce lead time and errors.
  • Govern end‑to‑end analytical method lifecycle: development, transfer, verification, qualification, validation, and ongoing improvements.
  • Lead technology transfers and partner with clients/contract labs for method implementation and issue resolution.
  • Oversee timely investigations, risk assessments, root cause analysis, and effective CAPAs; contribute to change controls and APR/PQR.
• Leadership, culture, and stakeholder engagement
  • Build, develop, and lead managers and teams; set clear goals,…