Senior Director, IT Compliance & Governance (Contract)

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 & 3rd 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, dependency tracking, executive reporting, vendor coordination, & delivery escalation

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 for US, Canada & EU markets, SOX, & privacy/transparency regulations
• Strong skills designing, enabling & auditing compliant IT operational processes, including SDLC, Change, Access, Inventory, Data Protection/Backup, & Service Continuity Management
• 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, and maintain strong attention to detail & accuracy
• Proven ability to set schedules & meet deadlines