This role serves as the technical expert and lead for driving changes in the CSV/CSA domain by moving from static compliance to dynamic risk-based assurance with a focus on AI-driven platforms
Job Summary
This role serves as the technical expert and lead for driving changes in the CSV/CSA domain by moving from static compliance to dynamic risk-based assurance with a focus on AI-driven platforms.
The position requires managing multiple computer system validation projects while ensuring all resource expenditures align with budgets and providing input to Software Development Lifecycle processes.
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 and lead for driving changes in the CSV/CSA domain by moving from static compliance 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
Generative AI and LLM risk assessment
Continuous Validation loop implementation
Agile and Waterfall project approaches
Automated testing tool proficiency
Python R or SQL data auditing skills
Global regulatory body inspection experience
Collaborative spirit and bold ingenuity
Key Requirements
Bachelor's degree required
10+ years in Quality Assurance Compliance
7+ years in software lifecycle methodologies
5+ years validation systems using CSA
Experience with FDA MHRA Health Canada EMA inspections