Position Overview
Job Description
Insight Global is seeking an IT Compliance Senior Manager local to Richmond, VA, or Raleigh, NC. This lead is highly skilled in Computer Systems Validation (CSV) with strong GxP experience and responsible for the development, maintenance, and communication of global policies, procedures, best practice guidance and appropriate risk-based methodologies. They will work closely with Business Units, IT teams, Quality, and Regulatory functions to define computer system validation requirements and ensure IT project delivery, application management and change management solutions, including Veeva applications, are managed in compliance with Pharmaceutical and Manufacturing industry regulations and department procedures.
This lead must have 7+ years' experience in: pharmaceutical business processes with manufacturing and IT solutions, working with pharmaceutical industry regulations and guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), a Computer Systems Valid...