IT Solution Manager – GxP Compliance and Validation

On behalf of a client in the pharmaceutical industry, we are looking for an IT Solution Manager to support IT compliance and validation activities for projects at a manufacturing site. Main Responsibilities

• Lead the scoping, preparation and completion of IT Risk Assessments (ITRA)
• Identify IT assets, interfaces, risks and required mitigation measures
• Complete IT compliance deliverables, including ITPSE and Disaster Recovery Plans
• Review and sign Design Qualification (DQ) and Validation Plan (VPL) documents from an IT perspective
• Ensure IT requirements, risk controls and testing activities are documented and traceable
• Facilitate workshops with stakeholders across IT, automation, quality, facilities and suppliers
• Support IT readiness for FAT and SAT activities
• Maintain documentation and review records in line with GxP and audit requirements

Key Requirements

• Knowledge of GxP requirements
• Proven experience as an IT Solution Manager, IT owner or similar role in a regulated environment
• Hands-on experience preparing IT Risk Assessments and IT validation documentation
• Experience reviewing DQ and VPL documents
• Understanding of industrial IT environments, including networks, PLC/SCADA interfaces, servers, endpoints, backup and cybersecurity
• Familiarity with FAT and SAT processes
• Strong documentation, stakeholder management and workshop facilitation skills
• Knowledge of GDPR and cybersecurity practices for industrial systems is an advantage

Other Details Assignment duration:1/12/2026 - 30/06/2027 Location: Gentofte