Senior Director, IT Compliance & Governance (Contractor)
Core
Senior IT leader ensuring FDA inspection success through IT GxP compliance and driving the delivery of a technology portfolio for BLA, inspection, and commercial launch readiness.
Role type
Senior Director, IT Compliance & Governance (Contractor)
Builds
IT GxP compliance assessments, remediation plans, evidence readiness, and a technology portfolio of dozens of critical projects.
Domain
Biotechnology / Pharma / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IT GxP compliance (Part 11), SOX compliance, SDLC management (GAMP 5), FDA inspection leadership, IT project portfolio management, IT governance, budget planning, policy/SOP development, cross-functional team leadership
Preferred skills
SSAE-18 SOC report reviews, Data Integrity/Computer System Assurance program leadership, complex commercial launch program management, Smartsheet, SharePoint, Box, Veeva Vault
Technologies
GRC tools, QMS tools, LMS tools, Smartsheet, SharePoint, Box, Veeva Vault
Responsibilities
Lead IT GxP compliance assessments and remediation plans for FDA inspections; oversee auditable IT activities (system validation, change control, access management); manage IT project portfolio prioritization, status reporting, and dependency tracking; coordinate IT Council governance, procurement, and budget forecasting; define and enforce IT governance policies and SOPs; serve as examiner-facing interface for audits and inspections.
Seniority
Senior Director, hands-on IC with strategic oversight