CSV Governance Lead

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 our IT 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 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 youll 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 youll do

• Maintain global oversight of computerized system validation
• Own and update all related procedures guidance documents and training materials
• Lead a global network of local process owners and support them in daily process questions
• Identify risks and improvement opportunities using audit inspection and stakeholder feedback
• Ensure full inspection readiness including documentation training and process evidence
• Communicate process changes and performance indicators to all impacted stakeholders

Interested For this role were looking for the following education experience and skills

• Bachelors or masters degree in a information technology engineering or any relevant discipline
• Strong understanding of GxP regulatory expectations for system validation including FDA EMA OECD
• Experience with validation of digital systems in regulated environments
• Strong understanding of regulatory expectations for system validation and user access control
• Ability to lead crossfunctional networks and drive alignment across different regions
• Excellent communication skills and ability to simplify complex requirements
• 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!

About us
UCB is a global biopharmaceutical company focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe inspired by patients and driven by science.

Why work with us
At UCB we dont just complete tasks we create value. We arent afraid to push forward collaborate and innovate to make our mark for patients. We have a caring supportive culture where everyone feels included respected and has equal opportunities to do their best work. We go beyond to create value for our patients and always with a human focus whether thats on our patients our employees or our planet. Working for us you will discover a place where you can grow and have the freedom to carve your own career path to achieve your full potential.

At UCB weve embraced a hybrid-first approach to work bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.