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The job posting seeks a Supervisor for FDA Computer System Validation within RSM's Business Applications Risk Consulting team. The ideal candidate will lead FDA IT Compliance and Validation practices while ensuring adherence to regulatory standards and improving data integrity for clients in FDA-regulated industries.
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Job Summary
Lead and expand our FDA IT Compliance, Validation, and Technology Risk practice, blending traditional CSV leadership with emerging expectations from FDA’s updated CSA guidance.
Oversee creation of risk-based requirements, validation strategies, traceability matrices, protocols, testing evidence, and summary reports, applying FDA’s CSA testing philosophy.
Provide coaching, mentoring, and oversight to junior validation/assurance consultants and support practice development activities including methodology updates, templates, accelerators, and training programs.
Matching Summary
Match Score: 75
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The job posting seeks a Supervisor for FDA Computer System Validation within RSM's Business Applications Risk Consulting team. The ideal candidate will lead FDA IT Compliance and Validation practices while ensuring adherence to regulatory standards and improving data integrity for clients in FDA-regulated industries.
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Salary
Base: $85,100 - $161,700; Bonus/Equity: discretionary bonus based on firm and individual performance; Benefits: competitive benefits and compensation package
Skills & Requirements
Must-have
FDA CSA Guidance 2026
QMSR requirements
data integrity principles
GxP compliance
ALCOA+ data integrity controls
risk-based requirements
unscripted testing
Nice-to-have
cybersecurity frameworks
supporting clients during inspections
security controls
SOD
ITGCs
Key Requirements
4+ years of experience in CSV/CSA, data integrity, or technology risk roles
Bachelor’s degree in Computer Science, MIS, Engineering, Life Sciences, or equivalent experience
Experience assessing and testing systems for electronic records/e-signatures
Hands-on experience with data integrity assessments, data migration validation, and SaaS vendor assurance