This role serves as the technical expert leading Computer System Validation and Assurance while driving a shift to dynamic, risk-based assurance with a focus on AI-driven platforms
Job Summary
This role serves as the technical expert leading Computer System Validation and Assurance while driving a shift to dynamic, risk-based assurance with a focus on AI-driven platforms.
The position requires managing multiple validation projects, ensuring budget alignment, and providing technical direction for continuous improvement of IT services in a GxP regulated environment.
BeOne Medicines offers a comprehensive benefits package including medical, dental, vision, 401(k), life insurance, paid time off, and opportunities for discretionary equity awards.
Matching Summary
This role serves as the technical expert leading Computer System Validation and Assurance while driving a shift to dynamic, risk-based assurance with a focus on AI-driven platforms.
Salary
Base: $172,500.00 - $232,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness
Skills & Requirements
Must-have
Computer System Validation CSA methodologies
21 CFR Part 11 and Annex 11 compliance
AI/ML system validation experience
GAMP 5 2nd Edition expertise
Cloud platform validation AWS Azure GCP
Internal audit management and execution
Cross-functional team leadership
Nice-to-have
Agile and Waterfall project approaches
Generative AI risk assessment skills
Continuous Validation loop implementation
Python R SQL data pipeline auditing
Collaborative spirit and bold ingenuity
Global regulatory inspection support
Mentoring and talent development focus
Key Requirements
Bachelor's degree required
10+ years in Quality Assurance Compliance
7+ years in software lifecycle methodologies
2+ years focused on AI/ML or Advanced Analytics
Experience managing regulatory inspections for FDA EMA MHRA