Supervisor, FDA Computer System Validation - Business Applications Risk Consulting

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We are seeking an experienced Computer System Assurance (CSA) & Data Integrity Supervisor to lead and expand our FDA IT Compliance, Validation, and Technology Risk practice. This role blends traditional CSV leadership with emerging expectations from FDA’s updated CSA guidance (Feb 3, 2026), QMSR requirements, experience with and working understanding of data integrity principles, systems security and controls design, and data migration/data quality validation for regulated (GxP) digital systems.

The ideal candidate will provide strategic oversight across the full system lifecycle—from requirements through regulatory test script design, testing, data migration, and ongoing assurance—to ensure our clients maintain audit‑ready, inspection‑credible systems in alignment with FDA expectations.

We are looking for an experienced Validation Supervisor to develop and grow our FDA IT Compliance and Validation practice.

Key Responsibilities

Regulatory & Quality Leadership

• 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
• Assist in development and delivery of training and awareness programs on CSA, data integrity, QMSR requirements across firm lines of service

Computer System Assurance & Validation Delivery

• 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
• Apply FDA’s CSA testing philosophy (e.g., unscripted testing, ad hoc testing, vendor reuse) to maximize efficiency and assurance
• Evaluate proposed changes to validated computer systems and recommend appropriate CSA/CSV activities based on process risk and patient impact

Data Integrity, Data Migration, and Data Quality Validation

• Partner with service line colleagues in conducting assessments of ALCOA+ data integrity controls across applications, integrations, and business processes
• Help define data flow diagrams and system interaction maps that support data integrity and security analyses

Security-by-Design, Controls, and Risk Management

• Partner with security architects and SOD teams to ensure compliant access models, change control processes, and control operation testing are in place
• Assess cyber risk impacts on validated systems as part of CSA risk methodology

Project & Team Leadership

• Act as CSA/CSV Lead for client projects; manage internal project resources and coordinate with cross-functional teams.
• Integrate validation activities into broader project timelines in partnership with engagement project managers
• Provide coaching, mentoring, and oversight to junior validation/assurance consultants
• Support practice development activities including methodology updates, templates, accelerators, and training programs

Required Education and Experience

• 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).
• Excellent leadership, communication, presentation, and project management skills.

Preferred Qualifications

• Experience with cloud ERP systems (NetSuite, SAP, D365) in regulated environments
• Familiarity with cybersecurity frameworks (NIST CSF, ISO 27001) as they apply to GxP systems
• Prior supervisory or team‑lead experience
• Knowledge of security controls, SOD, and ITGCs as applied to regulated systems
• Experience interacting with FDA or supporting clients during inspections

At RSM, we offer a competitive benefits and compensation package for all our people. We offer flexibility in your schedule, empowering you to balance life’s demands, while also maintaining your ability to serve clients. Learn more about our total rewards at https://rsmus.com/careers/working-at-rsm/benefits.

All applicants will receive consideration for employment as RSM does not tolerate discrimination and/or harassment based on race; color; creed; sincerely held religious beliefs, practices or observances; sex (including pregnancy or disabilities related to nursing); gender; sexual orientation; HIV Status; national origin; ancestry; familial or marital status; age; physical or mental disability; citizenship; political affiliation; medical condition (including family and medical leave); domestic violence victim status; past, current or prospective service in the US uniformed service; US Military/Veteran status; pre-disposing genetic characteristics or any other characteristic protected under applicable federal, state or local law. 

Accommodation for applicants with disabilities is available upon request in connection with the recruitment process and/or employment/partnership. RSM is committed to providing equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please call us at 800-274-3978 or send us an email at careers@rsmus.com.

RSM does not intend to hire entry level candidates who will require sponsorship now OR in the future (i.e. F-1 visa holders). If you are a recent U.S. college / university graduate possessing 1-2 years of progressive and relevant work experience in a same or similar role to the one for which you are applying, excluding internships, you may be eligible for hire as an experienced associate.

RSM will consider for employment qualified applicants with arrest or conviction records. For those living in California or applying to a position in California, please click here for additional information.

At RSM, an employee’s pay at any point in their career is intended to reflect their experiences, performance, and skills for their current role. The salary range (or starting rate for interns and associates) for this role represents numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, location, etc. As such, pay for the successful candidate(s) could fall anywhere within the stated range.

Compensation Range: $85,100 - $161,700