This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms
Job Summary
This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms.
The position requires managing multiple validation projects, developing standards for Generative AI integration, and ensuring compliance with cGxP regulations including 21 CFR Parts 11, 210, and 211.
BeOne Medicines offers a competitive salary range of $143,700 to $193,700 annually along with comprehensive benefits including medical, dental, vision, 401(k), and discretionary equity awards.
Matching Summary
This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms.
Salary
Base: $143,700.00 - $193,700.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary equity awards and Employee Stock Purchase Plan available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off
Skills & Requirements
Must-have
Computer System Validation CSA expertise
21 CFR Part 11 and Annex 11 compliance
AI/ML system validation experience
GAMP 5 methodology application
Cloud platform validation AWS Azure GCP
Cross-functional team leadership
Nice-to-have
Generative AI risk-based assurance
Continuous validation loop implementation
Agile and Waterfall project management
Python R SQL auditing skills
Collaborative spirit and bold ingenuity
Key Requirements
5+ years validation systems using CSA methodologies
7+ years software lifecycle methodologies
2 years focused on AI/ML or Advanced Analytics
Expert knowledge of GAMP 5 2nd Edition
Experience validating enterprise systems on AWS Azure or GCP