IT Solution Manager – GxP Compliance and Validation
emagine
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
- 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
Assignment duration:1/12/2026 - 30/06/2027
Location: Gentofte