IT Compliance & Computer System Validation Manager (m/f/x)

In this role you are responsible for ensuring that all our IT systems supporting GxP activities are compliant with applicable regulatory requirements and they are validated throughout their entire lifecycle. Acting as a key stakeholder to IT, Quality Assurance and the business, this position enables secure, efficient and inspection-ready digital solutions, supporting regulated operations.

Key Responsibilities:

• Ensure GxP-compliant operation and lifecycle validation of IT systems in line with GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, and related regulations.
• Own and maintain IT QMS documentation; manage IT-related risk assessments, CAPAs, deviations, and change controls.
• Lead and support CSV activities from system classification and validation planning through testing, release, and decommissioning.
• Validate a wide range of systems including clinical, laboratory, manufacturing, ERP, document management, and cloud/SaaS solutions.
• Ensure vendor assessment and supplier qualification using risk-based, scalable validation approaches.
• Bridge IT, Quality, and business interests, providing guidance during implementations, upgrades, and audits.
• Review and approve validation deliverables and train system owners and users on compliance expectations.