BeOne Medicines Ltd is seeking a Director of Computer System Compliance to lead Computer System Validation and Assurance efforts, focusing on dynamic, risk-based compliance for IT systems, particularly in AI-driven environments. The ideal candidate will have extensive experience in quality assurance, compliance, and validation within regulated environments, along with strong project management and leadership skills
Job Summary
This position will serve as the technical expert and lead for Computer System Validation/Computer System Assurance, (CSV/CSA) Data Integrity & IT Compliance for IT Systems.
The individual will be responsible for driving changes in the CSV/CSA domain by moving from static and paper-heavy compliance to dynamic and risk-based assurance with a specific focus on AI-driven platforms.
The company offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
Matching Summary
Match Score: 85
BeOne Medicines Ltd is seeking a Director of Computer System Compliance to lead Computer System Validation and Assurance efforts, focusing on dynamic, risk-based compliance for IT systems, particularly in AI-driven environments. The ideal candidate will have extensive experience in quality assurance, compliance, and validation within regulated environments, along with strong project management and leadership skills.
Salary
$172,500.00 - $232,500.00 annually; Annual bonus plan and discretionary equity awards; Comprehensive benefits package
Skills & Requirements
Must-have
Computer System Validation/Assurance
Data Integrity
IT Compliance
AI-driven platforms
cGxP, CFR 21 Parts 11, Annex 11
Risk-based approaches
Nice-to-have
Dynamic and risk-based assurance
Continuous improvement of IT services
Collaborate with Quality systems teams
Key Requirements
5+ years validation systems using Computer System Assurance methodologies
7+ years in software lifecycle methodologies, 21CFR Part 11 compliance, and GxP computer systems validation/ computer system assurance with at least 2 years focused on AI/ML or Advanced Analytics
10+ years in Quality Assurance / Compliance including managing regulatory inspections for GxP, SOx system for multiple international regulatory bodies
Bachelor’s degree with minimum 10 years of relevant work experience