This role serves as the technical expert leading Computer System Validation and Assurance with a specific focus on AI-driven platforms
Job Summary
This role serves as the technical expert leading Computer System Validation and Assurance with a specific focus on AI-driven platforms.
The position requires managing multiple validation projects while ensuring alignment with regulatory standards like cGxP, 21 CFR Part 11, and Annex 11.
BeOne Medicines offers a competitive salary range of $172,500 to $232,500 annually along with comprehensive benefits including equity awards.
Matching Summary
This role serves as the technical expert leading Computer System Validation and Assurance with a specific 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
Regulatory inspection management FDA EMA MHRA
Risk-based assurance approaches
Nice-to-have
Generative AI and LLM implementation knowledge
Agile and Waterfall project management
Cross-functional team leadership skills
Continuous improvement mindset
Collaborative spirit in global teams
Key Requirements
Bachelor's degree required
10+ years in Quality Assurance and Compliance
7+ years in software lifecycle and GxP validation
2+ years focused on AI/ML or Advanced Analytics
Experience managing regulatory inspections for international bodies