Senior Director, Quality Control

Role 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 the site QC organization, develop the analytical strategy that enables right‑first‑time data, timely disposition, and sustained regulatory compliance. Operate within the global quality leadership network while setting the QC vision and roadmap, building high‑performing teams across analytical, microbiology, and environmental monitoring, and elevating performance through governance, digital systems, and continuous improvement.

Company Overview

FUJIFILM Biotechnologies Texas is dedicated to developing the next vaccine and advancing cell and gene therapies. Our state‑of‑the‑art biomanufacturing facility in College Station combines a small‑town feel with vibrant culture, top‑notch schools, and proximity to major hubs. FUJIFILM is globally headquartered in Tokyo with over 70,000 employees across healthcare, electronics, business innovation, and imaging, guided by the Group Purpose of “giving our world more smiles.”

Responsibilities

• 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, provide coaching, and implement succession and engagement strategies.
  • Recruit and retain top talent; address performance gaps in partnership with People & Culture.
  • Collaborate across Manufacturing, MSAT, Process Development, QA, Supply Chain, EHS, Facilities/Metrology, Validation/CSV, and Program Management to enable NPI and continuous improvement.
  • Serve as primary QC liaison to site leadership and clients for analytical controls, quality agreements, and method strategy.

Minimum Education and Experience Requirements

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related scientific field + 12+ years progressive cGMP Quality Control experience in biopharmaceutical/biologics or advanced therapies, or Master’s degree in the same fields + 12+ years experience.
• 4+ years leading and developing leaders (Managers/Supervisors).
• Experience working in a changing, project‑driven organization.
• Demonstrated experience in analytical method lifecycle (development, transfer, verification, qualification, validation), technology transfer, stability programs, and environmental/utility monitoring.
• Proven success leading regulatory/client inspections and maintaining data‑integrity compliance.
• Experience implementing and managing QC digital systems (e.g., LIMS/ELN/LES, chromatography data systems) and familiarity with equipment qualification and computerized system validation.

Preferred Qualifications

• Master’s degree or Ph.D.
• CDMO experience strongly preferred.

What You’ll Bring

• Executive leadership with a track record of building high‑performing QC organizations and developing leaders.
• Strong command of cGMP, global regulations, and ICH guidelines; expert in inspection readiness and response.
• Strategic, data‑driven decision‑making; adept at KPI governance and cost‑to‑serve transparency.
• Deep technical breadth across analytical, microbiology, stability, EM/UM programs, and digital lab systems.
• Exceptional communication and influence with executives, regulators, clients, and cross‑functional partners.

Work Model and Scope

• Site‑based leadership role at College Station, TX, supporting laboratory and office environments.
• Potential travel up to 10% for audits, client interactions, and global forums.
• Leads through managers with a broad span of control across analytical, microbiology, and EM/UM laboratories.

Benefits

We offer a robust benefits package including medical, dental, vision, and prescription drug coverage with the option of a Health Savings Account and company contributions. An industry‑leading 401(k) savings plan, insurance coverage, employee assistance programs, and various wellness incentives are provided. We support work‑life balance with paid vacation time, sick time, and company holidays, and foster a supportive environment that enriches both personal and professional growth.