Senior IT GxP Compliance & Governance Leader

4D Molecular Therapeutics; United States; On-site; USD 168,000 - 187,000; Full time

Job summary

4D Molecular Therapeutics is seeking an IT Compliance & Governance Consultant reporting to the Sr. VP, IT & Facilities.

You will lead IT GxP compliance assessments, remediation plans, evidence readiness, and inspection responses while guiding a portfolio of critical IT programs ensuring readiness for FDA inspections. You will partner with QA CSV/CSA, Finance, and Legal Compliance to align policies, drive governance improvements, and manage complex tech portfolios across BLA, inspections, and

Qualifications

• Bachelor’s degree in Life Science or Computer Science.
• 15+ years IT GxP compliance responsibility.
• Experience leading IT compliance for FDA inspections.
• Strong writing and communication skills.

Responsibilities

• Lead IT GxP compliance assessments and remediation plans.
• Coordinate IT evidence, storyboards, and inspection responses.
• Collaborate with QA CSV/CSA, Finance, and Legal to align policies.
• Manage observations and CAPAs through remediation.

Skills

IT GxP compliance

SOX ITGC

GAMP5 SDLC

Data Integrity

Governance & audits

Cross-functional leadership

Education

Bachelor’s Degree in Life Science

Bachelor’s Degree in CS

Tools

Smartsheet

SharePoint

Box

Veeva Vault

Job description

4D Molecular Therapeutics is seeking an IT Compliance & Governance Consultant reporting to the Sr. VP, IT & Facilities.

You will lead IT GxP compliance assessments, remediation plans, evidence readiness, and inspection responses while guiding a portfolio of critical IT programs ensuring readiness for FDA inspections. You will partner with QA CSV/CSA, Finance, and Legal Compliance to align policies, drive governance improvements, and manage complex tech portfolios across BLA, inspections, and