Director, Computer System Compliance

This is a Director-level position responsible for leading Computer System Validation/Computer System Assurance and Compliance efforts across the company. The individual will develop standards, set direction, and build repeatable processes for Generative AI and Large Language Models used in clinical or manufacturing settings.

Requirements

• 5+ years validation systems using Computer System Assurance methodologies including Agile and Waterfall approaches.
• 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 (e.g, MHRA, Health Canada, FDA, EMA).

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness