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