Senior Director, IT Compliance & Governance (Contract)

Attention recruitment agencies: All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future. 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients. The Company’s lead product candidate 4D-150 is designed to be a backbone therapy forming the foundation of treatment of blinding retinal vascular diseases by providing multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) with a single, safe, intravitreal injection, which substantially reduces the treatment burden associated with current bolus injections. The Company’s lead indication for 4D-150 is wet age-related macular degeneration, which is currently in Phase 3 development, and second indication is diabetic macular edema. The Company’s second product candidate is 4D-710, which is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery GENERAL SUMMARY:   Reporting to the Sr. VP, IT & Facilities, the IT Compliance & Governance Consultant is a senior IT leader with two mission-critical objectives: as IT’s examiner-facing leader, ensure FDA inspection success by leading IT GxP compliance assessments, remediation plans, evidence readiness, & inspection response; and 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; and 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—by internal teams, managed services, consultants & 3 rd  party service providers to ensure consistent, on-time, right-first-time execution.   Serve as a collaborative partner to QA CSV/CSA, Finance Compliance (SOX) & Legal Compliance (Privacy/Transparency) to align & improve governance & compliance policies/SOPs, & execute audit/inspection preparedness activities (e.g., risk-based storyboarding, control/procedure improvements, evidence readiness drills).   Act as escalation point & examiner-facing interface for IT portions of audits & health authority inspections; explain IT controls & CSV/CSA practices; coordinate IT evidence, storyboards & responses; & manage observations/CAPAs through remediation closure.   IT Council Project Portfolio:   Own & mature technology portfolio management practices that translate strategy into a clear, funded, executable roadmap with transparent status reporting for leadership decisions; oversee critical implementation programs & drive cross-functional alignment, escalation, dependency management, & delivery discipline.   Run portfolio intake, prioritization, categorization, risk/value assessment, dependency mapping, benefits tracking & portfolio reporting, with special focus on BLA, Inspection & Commercial Launch programs.   IT Governance:   Coordinate annual planning & IT Council/steering cadences, IT procurement coordination, & budget development/forecasting & BvA spend tracking.   Define, implement, & enforce IT governance across verticals through policies, SOPs, & fit-for-purpose processes, establishing ways of working (e.g., project/program governance, IT cadences, KPI/OKR framework) that improve performance & maturity.   Maintain dotted-line/matrixed governance for IT project managers, IT compliance, IT procurement & system validation staff to drive consistent execution, standard work, & audit/inspection readiness across systems & programs.   QUALIFICATIONS :   Experience:   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, including examiner-facing preparation & response   Recent roles demonstrating expertise managing transparent IT project portfolios that enable effective steering committee oversight & portfolio health monitoring   Annual external audits of SOX IT General Control design & effectiveness, Segregation of Duties, & SSAE-18 SOC report reviews a plus   Multiple lab, scientific &/or financial software implementations (SDLC/Change Mgmt) as IT lead or compliance/validation lead.    Direct involvement as IT lead or compliance/validation lead in one or more Data Integrity or Computer System Assurance programs   Experience leading complex, cross-functional technology portfolios or commercial launch programs with dozens of concurrent projects, including roadmap governance,