RSM US LLP

Supervisor, FDA Computer System Validation – Business Applications Risk Consulting

RSM US LLP

full-time

Posted on:

Location Type: Office

Location: Philadelphia • Massachusetts • North Carolina • United States

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Salary

💰 $85,100 - $161,700 per year

About the role

  • Lead and expand our FDA IT Compliance, Validation, and Technology Risk practice.
  • Interpret and apply FDA CSA Guidance 2026, FDA’s QMSR, 21 CFR Part 11, Annex 11, and GAMP 5 to client systems and engagements.
  • Serve as a trusted advisor on GxP compliance, data integrity, and system assurance best practices.
  • Lead the end-to-end delivery of CSA/CSV projects, including planning, execution, reporting, and inspection readiness.
  • Oversee creation of risk-based requirements, validation strategies, traceability matrices, protocols, testing evidence, and summary reports.
  • Evaluate proposed changes to validated computer systems and recommend appropriate CSA/CSV activities based on process risk and patient impact.

Requirements

  • 4+ years of experience in CSV/CSA, data integrity, or technology risk roles within FDA-regulated industries or consulting.
  • Bachelor’s degree in Computer Science, MIS, Engineering, Life Sciences, or equivalent experience.
  • Strong understanding of: FDA CSA Guidance (Feb 3, 2026), FDA QMSR (ISO 13485 alignment), 21 CFR Part 11 / Annex 11, GAMP 5 (2nd Edition), 21 CFR 210/211 (as applicable)
  • Experience assessing and testing systems for electronic records/e-signatures requirements.
  • Hands-on experience with data integrity assessments, data migration validation, and SaaS vendor assurance (e.g., NetSuite, SAP, D365, LMS, e-signature platforms).
Benefits
  • Flexibility in your schedule, empowering you to balance life’s demands
  • Competitive benefits and compensation package
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
CSVCSAdata integritytechnology riskrisk-based requirementsvalidation strategiestraceability matricesprotocolstesting evidenceinspection readiness
Soft Skills
leadershipcommunicationadvisoryplanningexecutionreporting