Senior Director, IT Compliance & Governance (Contract)

Role overview A senior contract leader is needed to own IT compliance and governance for a late-stage clinical biotechnology organization preparing for an FDA inspection and potential commercial launch. The role combines examiner-facing regulatory readiness with IT portfolio leadership, spanning GxP/SOX compliance, a Council-governed technology portfolio, and enterprise IT governance.

Responsibilities - Lead IT GxP compliance assessments, remediation plans, and evidence readiness in support of an upcoming health-authority inspection, serving as the examiner-facing IT representative. - Oversee auditable IT activities including system validation, periodic review, backup/restore testing, change control, SOX ITGC reviews, and access/inventory management across internal teams and third-party providers. - Partner with QA CSV/CSA, Finance Compliance, and Legal Compliance to align policies, SOPs, and inspection preparedness activities such as risk-based storyboarding, control improvements, and evidence drills. - Own portfolio management practices for dozens of concurrent BLA, inspection, and commercial-launch programs, including intake, prioritization, dependency mapping, benefits tracking, and executive status reporting. - Coordinate annual planning, IT Council cadences, IT procurement, budget development/forecasting, and budget-versus-actual tracking. - Define and enforce IT governance through policies, SOPs, KPI/OKR frameworks, and matrixed oversight of project managers, compliance, procurement, and validation staff.

Requirements - 15+ years of IT GxP (e.g., 21 CFR Part 11) compliance responsibility. - 12+ years directly managing or auditing IT operational processes, plus 10+ years developing SDLC aligned with GAMP 5 principles. - 8+ years in a senior IT leadership role within biotech or pharma leading compliance and project teams. - Direct experience as IT, compliance, or validation lead for at least one FDA or comparable health-authority inspection. - Demonstrated track record managing transparent IT project portfolios with steering-committee oversight and portfolio health reporting. - Bachelor's degree in a life science or computer science field; GxP, SOX, and privacy-related certifications strongly preferred.

Nice to have - Hands-on experience with annual SOX ITGC design/effectiveness audits, Segregation of Duties reviews, and SSAE-18 SOC report reviews. - Multiple lab, scientific, or financial system implementations as IT or validation lead, including Data Integrity or Computer System Assurance programs. - Familiarity with GRC, QMS, and LMS platforms, along with collaboration tools such as Smartsheet, SharePoint, and Veeva Vault.

Benefits and work setup - Hourly compensation range of $122.00–$136.00, with final rate dependent on location, experience, and tenure. Sedentary, office-based working conditions.