Make your mark for patients
We are looking for a CSV (Computerized System Validation) Governance Lead who is digital-savvy, collaborative and proactive to join us in ourIT Compliance Solutions team, based in our Brussels office in Belgium.
About the role
You will be working in a team that ensures all digital systems used in regulated activities are reliable, safe and fully compliant with industry expectations. In this role, you will lead the Corporate process for validation of computerized systems and associated processes (access management, change control, periodic review...). You will lead the process digitalization and own the associated tools. You will be responsible for defining how the process works, ensuring it is applied consistently across all departments and regions, and keeping it aligned with regulatory requirements. You will oversee process documentation, training, continuous improvement and inspection readiness while guiding a network of colleagues across different sites. This is a role for someone who enjoys structure, clarity, and collaboration in a highly regulated environment.
Who you’ll work with
You will be working in a team that collaborates closely with quality, information technology, manufacturing, research and development and other business functions. You will also lead a global community of local process owners who apply the computerized system validation in their regions. Together, you will ensure consistency, compliance, and continuous improvement across the organization. You will interact with stakeholders at all levels, including senior quality leads, business owners of digital systems, and colleagues preparing for audits and inspections.
What you’ll do
1. Maintain global oversight of computerized system validation
2. Own and update all related procedures, guidance documents and training materials
3. Lead a global network of local process owners and support them in daily process questions
4. Identify risks and improvement opportunities using audit, inspection and stakeholder feedback
5. Ensure full inspection readiness, including documentation, training and process evidence
6. Communicate process changes and performance indicators to all impacted stakeholders
Interested? For this role we’re looking for the following education, experience and skills
7. Bachelor’s or master’s degree in a information technology, engineering or any relevant discipline
8. Strong understanding of GxP regulatory expectations for system validation including FDA, EMA, OECD
9. Experience with validation of digital systems in regulated environments
10. Strong understanding of regulatory expectations for system validation and user access control
11. Ability to lead cross‑functional networks and drive alignment across different regions
12. Excellent communication skills and ability to simplify complex requirements
13. Experience with continuous improvement, change management or process governance
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!