Director, Digital Governance
Core
Accountable owner for IT governance, data governance, and AI/agent governance in a GxP clinical-research environment, designing lifecycle controls and operationalizing inspection-ready frameworks.
Role type
Director, Digital Governance (hands-on IC)
Builds
AI and agent governance frameworks, data governance policies, and KPI-driven governance dashboards
Domain
Clinical research, biotech/pharma, GxP regulatory compliance, AI governance
Deliverable
production ML models | infrastructure
Required skills
IT governance in regulated environments, GxP/GCP/21 CFR Part 11/Annex 11 compliance, data governance framework design, SOP authoring and operationalization, KPI-driven dashboard creation, AI governance and Responsible AI principles, stakeholder influence in matrixed organizations
Preferred skills
FDA/EMA good machine learning/AI practice principles, EU AI Act, ISO/IEC 42001
Technologies
GAMP 5, CSA, ALCOA+
Responsibilities
Operate IT SOPs as inspection-defensible controls with traceability and effectiveness monitoring; Design, build, and operate AI and agent governance frameworks including lifecycle management and validation; Own data governance framework establishing metadata, lineage, and quality standards; Define and operate KPI-driven dashboards for governance visibility; Partner with Quality and Responsible AI Board to translate principles into executable controls
Seniority
Director, strategic execution & mentorship
