The 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, driving changes towards dynamic and risk-based assurance with a focus on AI-driven platforms
Job Summary
The 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, driving changes towards dynamic and risk-based assurance with a focus on AI-driven platforms.
Responsibilities include leading CSV/CSA deliverables, participating in the assessment of new guidance, managing project resources, performing risk assessments, and providing technical expertise in accordance with cGxP and other regulations.
The company offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), and opportunities for stock ownership.
Matching Summary
The 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, driving changes towards dynamic and risk-based assurance with a focus on AI-driven platforms.
Salary
$172,500.00 - $232,500.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Comprehensive benefits package
Skills & Requirements
Must-have
Computer System Validation/Assurance
Data Integrity
IT Compliance
cGxP, CFR 21 Parts 11
GAMP 5 expert
AI/ML validation experience
Nice-to-have
Collaborative
Highly motivated
Passionate interest in fighting cancer
Continuous improvement of IT services
Engaged and effective work environment
Key Requirements
5+ years validation systems using CSA methodologies
7+ years software lifecycle, 21CFR Part 11, GxP CSV/CSA
2+ years focused on AI/ML or Advanced Analytics
10+ years in Quality Assurance/Compliance
Experience managing regulatory inspections
Bachelor’s degree with minimum 10 years of relevant work experience