IT Compliance Senior Manager

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., 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. The salary for this role ranges from $155,000-$170,000, based on experience., IT contact for internal, financial, and ITGC audits; attend vendor audits as CSV and IT Compliance SME; coordinate completion of audit questionnaires by IT vendors

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, IT application development, and supporting Veeva within a regulated environment. Experience supporting Veeva applications, Manufacturing Execution Systems (MES), and participation in regulated system implementations such as Laboratory Information Management Systems (LIMS) is important. Experience working within compliance on a global scale is also essential., 4 year Bachelor’s Degree

-7+ years’ experience in: Pharmaceutical business processes with manufacturing and IT solutions

-Dealing with pharmaceutical industry regulations and guidelines (FDA 21 CFR Part 11, EU Annex 11, GxP, GAMP), ensuring compliance with international pharmaceutical regulations and company policies

-Computer Systems Validation (CSV) role (3+ years of leadership), providing system implementation expertise to Business Units and IT functions

-Experience supporting Veeva applications, Manufacturing Execution Systems (MES), and participation in regulated system implementations such as Laboratory Information Management Systems (LIMS)

-GxP inspections performed by regulating authorities

-Working with IT validation document repository (ValGenesis)

-Electronic signature solutions (Adobe and DocuSign), IT control management system (AuditBoard), and corporate quality management system (TrackWise and Veeva)

-IT application development, implementation, and support processes (project planning, software lifecycle, writing project deliverables)

-Strong communication and leadership skills to partner with IT leadership on business initiatives and coordinate IT risk reviews with stakeholders, reviewing and approving IT governance documents

-Developing and leading training programs to team members on CSV