Senior Director, Quality Control

Fujifilm • College Station, TX

1d • Onsite

About The Position

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: https://www.fujifilm.com/us/en/about/region/careers

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

Nice To Haves

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

Responsibilities

• Align site priorities to global strategy and partner closely with clients and regulators.
• Lead complex, impactful biologics programs and enable timely, compliant product disposition.
• Build the digital, technical and organizational capabilities to make an impact to patients around the world.
• 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.
• 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.
• 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.

Benefits

• medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions
• industry leading 401(k)savings plan
• insurance coverage
• employee assistance programs
• various wellness incentives
• paid vacation time, sick time, and company holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Executive