This role is accountable for the end-to-end global process that ensures AI-enabled systems used in GxP contexts are validated/qualified and maintained in a state of control throughout their lifecycle
Job Summary
This role is accountable for the end-to-end global process that ensures AI-enabled systems used in GxP contexts are validated/qualified and maintained in a state of control throughout their lifecycle.
Key responsibilities include contributing to and supporting the global AI validation/qualification process, owning and maintaining controlled documentation, and partnering with governance stakeholders.
The role requires enabling global deployment through training and guidance, defining process performance metrics, and supporting inspection readiness.
Matching Summary
This role is accountable for the end-to-end global process that ensures AI-enabled systems used in GxP contexts are validated/qualified and maintained in a state of control throughout their lifecycle.
Skills & Requirements
Must-have
AI validation/qualification process
GxP computerized systems validation
AI trustworthiness/credibility assessment
Controlled documentation and templates
Global process ownership
Nice-to-have
Influence without authority
Risk-based thinking
Training and coaching capability
Community of practice support
Key Requirements
Master’s degree with 10+ years QA experience
Bachelor’s degree with 12+ years QA experience
10+ years GxP computerized systems validation/qualification
Experience with AI governance in GxP
Working knowledge of AI trustworthiness/credibility assessment