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.

Job Description

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.

What you'll lead

• 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 required in Chemistry, Biochemistry, Microbiology, or related scientific field with 12+ years of progressive experience in cGMP Quality Control within biopharmaceutical/biologics or advanced therapies OR
• Master's degree required in Chemistry, Biochemistry, Microbiology, or related scientific field with 12+ years of progressive experience in cGMP Quality Control within biopharmaceutical/biologics or advanced therapies
• 4+ years of experience 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

Our programs are designed to focus on maintaining and enhancing all pillars of health with a robust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions. In addition, we offer an industry leading 401(k)savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

As part of any recruitment process, FUJIFILM Biotechnologies collects and processes personal data relating to job applicants. The organisation is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations and may share this as part of the global recruitment process with hiring managers in Europe and the United States.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.