Senior Director, Quality Control & Compliance

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 220,000 - 320,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid time off

Health Savings Account

Job summary

FUJIFILM Biotechnologies Texas is seeking a Senior Director of Quality Control to shape the site QC strategy and lead the organization across analytical, microbiology, and environmental monitoring. The role requires building high‑performing teams, ensuring inspection readiness, and aligning with global QC initiatives.

You will partner with regulators and clients to enable compliant product disposition, implement digital lab systems, and drive continuous improvement.

Qualifications

• Bachelor's or Master's degree in a relevant scientific field with 12+ years in cGMP QC within biopharmaceutical/biologics or advanced therapies.
• 4+ years leading and developing leaders (Managers/Supervisors).
• Experience in analytical method lifecycle (development, transfer, verification, qualification, validation), technology transfer, stability programs, and environmental/utility monitoring.
• Proven success in regulatory/client inspections and maintaining data integrity compliance.
• Experience implementing and managing QC digital systems (LIMS/ELN/LES) and familiarity with equipment qualification and computerized system validation.

Responsibilities

• Set and execute the site QC strategy and roadmap aligned to Global QC.
• Lead regulatory/client audits and deliver timely responses and commitments.
• Oversee QC operations across in‑process, release, stability, microbiology, and environmental monitoring to meet timelines and specs.
• Drive continuous improvement in workflows, documentation, and data integrity to reduce lead time and errors.
• Lead end‑to‑end analytical method lifecycle: development, transfer, verification, qualification, validation, and ongoing improvements.

Skills

Executive leadership

Quality strategy

Regulatory compliance

KPIs governance

Data integrity

Digital systems

Team leadership

Education

Bachelor's degree in Chemistry/Biochemistry/Microbiology or related

Master's degree in Chemistry/Biochemistry/Microbiology or related

Tools

LIMS/ELN/LES

Chromatography data systems

Job description

FUJIFILM Biotechnologies Texas is seeking a Senior Director of Quality Control to shape the site QC strategy and lead the organization across analytical, microbiology, and environmental monitoring. The role requires building high‑performing teams, ensuring inspection readiness, and aligning with global QC initiatives.

You will partner with regulators and clients to enable compliant product disposition, implement digital lab systems, and drive continuous improvement.