Salt Lake City, UT30+ days ago
ul>Ensure IT infrastructure, systems, and processes meet requirements under HIPAA, FDA 21 CFR Part 11, FDA QSR/QMSR (21 CFR Part 820), and SOC 2. Lead Computer System Validation (CSV) efforts for GxP-relevant systems including quality management, lab, and clinical platforms. The ideal candidate brings both strategic vision and operational depth: able to modernize infrastructure, build cybersecurity governance, protect proprietary neural research data, and prepare the organization for regulatory scrutiny, investor diligence, and hospital/enterprise customer security assessments.