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 ensuring governance integration and cross-functional alignment.
The role requires enabling global deployment through training and guidance, and driving continuous improvement and 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
controlled documentation and templates
AI trustworthiness/credibility assessment
LLM and Machine development lifecycle
Nice-to-have
influence without authority
risk-based thinking
training and coaching capability
cross-functional alignment
Key Requirements
Master’s degree with 10 years experience OR Bachelor’s degree with 12 years experience
Demonstrated experience in GxP computerized systems validation/qualification
Experience developing, maintaining, and deploying controlled documents
Familiarity with AI governance expectations in GxP contexts
Working knowledge of AI trustworthiness/credibility assessment concepts