Supervisor, Fda Computer System Validation - Business Applications Risk Consulting

12

Multiple Locations
Base: $85,100 - $161,700; bonus/equity: discretion...
**
Fda csa guidance 2026
Qmsr requirements
Data integrity principles
** 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. **

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

** 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. **

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

Work Rights

Not specified

Tailored Resume

Cover Letter