Senior Director, QC Strategy & Compliance

FUJIFILM Electronic Materials U.S.A., Inc.

College Station (TX)

On-site

USD 180,000 - 240,000

Full time

7 days ago
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Benefits offered by this job

Medical, dental, vision benefits with
401(k) plan
Paid vacation time and holidays

Job summary

FUJIFILM Biotechnologies Texas seeks a Senior Director of Quality Control to shape the site QC strategy, lead the analytics organization, and drive right-first-time data, timely disposition, and regulatory compliance from a College Station, TX base.

You will build capabilities across analytical, microbiology, and environmental monitoring, advancing governance, digital systems, and continuous improvement while partnering with global quality leadership.

Qualifications

  • Bachelor’s or Master’s degree in a relevant science with 12+ years of cGMP QC experience in biopharma/biologics or advanced therapies.
  • 4+ years of experience leading and developing leaders (Managers/Supervisors).
  • Experience with analytical method lifecycle, technology transfer, stability programs, and environmental/utility monitoring; regulatory inspections.

Responsibilities

  • Set and execute the site QC strategy and roadmap aligned to Global QC.
  • Oversee QC operations including in-process, release, stability, microbiology, and environmental/utility monitoring.
  • Lead regulatory inspections and ensure data integrity across systems.

Skills

Executive leadership
KPI governance
Cross-functional collaboration
Regulatory knowledge
Data-driven decision-making

Education

Bachelor’s degree in Chemistry, Biochemistry, Microbiology, or related field
Master’s degree in Chemistry, Biochemistry, Microbiology, or related field

Tools

LIMS/ELN/LES
Chromatography data systems

Job description

FUJIFILM Biotechnologies Texas seeks a Senior Director of Quality Control to shape the site QC strategy, lead the analytics organization, and drive right-first-time data, timely disposition, and regulatory compliance from a College Station, TX base.

You will build capabilities across analytical, microbiology, and environmental monitoring, advancing governance, digital systems, and continuous improvement while partnering with global quality leadership.

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