Job Description:
Insight Global is seeking an IT Compliance Lead local to their Richmond, VA, or Raleigh, NC, locations. 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 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 Validation (CSV) role, inspecting GxP's by regulating authorities, working with IT validation document repository, electronic signature solutions, and IT application development.
Day to day responsibilities include: determining strategy for IT compliance governance, partnering with IT leadership on business initiatives and supporting IT compliance team members to improve technical abilities and career development, maturing IT documentation, reviewing and approving IT governance and procedure documents, providing CSV and system implementation expertise to the Business Units and IT functions, providing oversight by coordinating IT risk reviews with the IT leadership team and stakeholders, and being the IT contact for internal, financial, and ITGC audits.