Sr. Compliance Specialist (Artificial Intelligence)
Core
Subject matter expert for AI governance, validation, and compliance in a GxP-regulated environment, establishing processes and controls for responsible AI lifecycle management.
Role type
Senior Compliance Specialist (AI Governance & Validation)
Builds
Compliance programs, SOPs, and test strategies for AI-enabled systems within GxP environments.
Domain
Life Sciences / Healthcare / Regulatory Compliance / Artificial Intelligence
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance, computerized systems validation, AI regulatory frameworks (FDA 21 CFR Part 11, EU AI Act, NIST), risk assessment, SOP development, audit leadership, project management
Preferred skills
Certifications in technology/compliance/audits, background in Computer Science or Engineering
Technologies
Compliance management software, Microsoft Office Suite
Responsibilities
Develop and implement compliance programs for AI governance and validation; Integrate AI-specific requirements into standard operating procedures; Execute AI-focused test strategies; Mentor team members on AI validation practices; Represent IT on enterprise AI governance committees; Support regulatory inspections and client audits
Seniority
Senior, hands-on IC
