[Hiring] Senior Director, IT Compliance & Governance @4D Molecular Therapeutics

Role Description

Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives:

• Ensure FDA inspection success by leading IT GxP compliance assessments, remediation plans, evidence readiness, & inspection response.
• Drive successful delivery of the IT Council-governed technology portfolio, which includes dozens of critical BLA, Inspection & Commercial Launch-readiness projects.

The role covers three core areas:

• IT compliance, primarily GxP & SOX.
• The IT Council project portfolio, including prioritization, status reporting, dependency management, & escalation, with special focus on BLA, Inspection & Commercial launch programs.
• IT governance, including IT Council coordination, IT procurement, budget planning/forecasting, policies, SOPs, & cross-functional ways of working.

Responsibilities

• IT Compliance:
  • Ensure 4DMT IT meets GxP, SOX & privacy requirements through an auditable control environment & strong evidence management.
  • Lead the IT GxP compliance assessment & remediation plan for the upcoming FDA inspection.
  • Oversee execution of auditable IT activities—system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews & access/inventory management.
  • Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency).
  • Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections.
• IT Council Project Portfolio:
  • Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap.
  • Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting.
• IT Governance:
  • Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting.
  • Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes.
  • Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff.

Qualifications

• 15+ years of IT GxP (e.g. Part 11) compliance responsibility required.
• 12+ years directly managing or auditing IT operational processes.
• 10+ years developing, implementing & maintaining SDLC in alignment with principles of GAMP 5.
• 8+ years of experience in a senior IT leadership position w/demonstrated ability to lead compliance & project teams within the Biotech or Pharma industry.
• Direct involvement as IT, compliance, or validation lead for at least one FDA or comparable health authority inspection.
• Recent roles demonstrating expertise managing transparent IT project portfolios.
• Annual external audits of SOX IT General Control design & effectiveness a plus.
• Multiple lab, scientific &/or financial software implementations as IT lead or compliance/validation lead.
• Experience leading complex, cross-functional technology portfolios or commercial launch programs.

Education

• Bachelor’s Degree in a Life Science or Computer Science.
• Certifications related to GxP, SOX & Privacy regulations, IT operations & project management strongly preferred.

Skills

• Strong knowledge of the IT implications of cGMP, GCP & ICH guidelines, Part 11/Annex 11, Computer System Assurance, Data Integrity guidelines.
• Strong skills designing, enabling & auditing compliant IT operational processes.
• Strong skills using & administering GRC, QMS & LMS tools required.
• Skills with Smartsheet, SharePoint, Box & Veeva Vault a plus.
• Ability to work with a diverse group of personalities & individuals at all levels.
• Excellent document authoring, review & writing skills.
• Strong verbal communication skills.
• Ability to work independently, multitask, & maintain strong attention to detail & accuracy.
• Proven ability to set schedules & meet deadlines.

Physical Requirements and Working Conditions

• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally.
• Working Conditions - The worker is not substantially exposed to adverse environmental conditions.

Compensation

Hourly compensation range: $122.00 - 136.00/hr. Please note, the hourly compensation range offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.

Equal Employment Opportunity

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.