Senior Director, QC Strategy & Global Compliance

FUJIFILM Biotechnologies; College Station (TX); On-site; USD 230,000 - 350,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Job summary

FUJIFILM Biotechnologies Texas seeks a Senior Director of Quality Control in College Station to shape site QC strategy, lead analytical programs, and ensure right-first-time data and timely disposition.

You will build and guide high-performing teams across analytical, microbiology, and environmental monitoring while partnering with global QC to drive governance and continuous improvement. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related field with 12+ years of progressive cGMP Quality Control experience.
• Master’s degree in Chemistry, Biochemistry, Microbiology, or related field with 12+ years of progressive cGMP QC experience.
• 4+ years of experience leading and developing leaders (Managers/Supervisors).
• Experience in analytical method lifecycle, technology transfer, stability programs, and environmental/utility monitoring.
• Proven success leading regulatory/client inspections and data integrity compliance.
• Experience implementing and managing QC digital systems (LIMS/ELN/LES).

Responsibilities

• Set and execute the site QC strategy and roadmap aligned to Global QC.
• Own inspection readiness; lead regulatory/client audits and responses.
• Oversee QC operations across in-process, release, stability, microbiology, and EM/UM.
• Drive continuous improvement in workflows, data integrity, and documentation.
• Lead method lifecycle governance: development, transfer, verification, qualification, validation.
• Manage budgets, headcount, and resource planning.

Skills

Executive leadership

cGMP knowledge

Regulatory inspections

KPI governance

Data-driven decision making

Cross-functional collaboration

Education

Bachelor's degree in Chemistry/Biochemistry/Microbiology

Master's degree in Chemistry/Biochemistry/Microbiology

PhD (preferred)

Tools

LIMS

ELN

Chromatography data systems

Job description

FUJIFILM Biotechnologies Texas seeks a Senior Director of Quality Control in College Station to shape site QC strategy, lead analytical programs, and ensure right-first-time data and timely disposition.

You will build and guide high-performing teams across analytical, microbiology, and environmental monitoring while partnering with global QC to drive governance and continuous improvement. Travel up to 10% may be required.