Make your mark for patients
To strengthen our GxP Compliance (Data Integrity and Digital Compliance) department, we are looking for a talented profile to fill the position of: Computerized Systems Quality Assurance (CSQA) - ERP, Braine l’Alleud, Belgium
About the role
The CSQA Specialist is responsible for ensuring that all GPvP/GCP/GLP relevant computerized systems across the organization are validated, compliant, and maintained according to regulatory requirements and industry best practices. This role provides expert guidance on CSV/CSA, data integrity, system lifecycle management and quality oversight of digital and automation initiatives within a pharmaceutical environment.
You will work with
You will work closely with the Head of GxP Data Integrity & Digital Compliance, Data Office, IT, Knowledge Management, and other key stakeholders. This role requires you to collaborate with cross-functional teams to address and mitigate data integrity risks and drive continuous improvement within UCB.
What you will do
Quality Oversight & Compliance
1. Provide senior‑level QA oversight for the full lifecycle of GxP computerized systems (from concept to retirement).
2. Ensure compliance with global health authority expectations (FDA, EMA, MHRA), industry standards (GAMP 5, ICH Q9/Q10), and data integrity principles (ALCOA+).
3. Review and approve validation deliverables such as validation plans, risk assessments, design, data integrity risk analysis, test strategies, test cases and validation reports.
4. Ensure adherence to internal policies, SOPs, and quality standards for computerized systems.
CSV/CSA Leadership
5. Lead and support Computerized System Validation (CSV) and Computer Software Assurance (CSA) activities using a risk-based approach.
6. Drive adoption of CSA principles to optimize and streamline validation effort while ensuring compliance.
7. Contribute to the development and continuous improvement of CSV/CSA frameworks, templates, and procedures.
Project & Stakeholder Management
8. Provide QA guidance to project teams during system implementation, upgrades, integrations, and migrations.
9. Partner with IT, QA, Patient Safety, Clinical, R&D, and Automation teams.
10. Facilitate cross-functional decision-making and serve as a key QA representative in system-related projects.
Vendor & Audit Management
11. Perform supplier qualification audits and quality assessments of technology partners.
12. Ensure that third‑party service providers and Software-as-a-Service (SaaS) systems meet regulatory and contractual requirements.
13. Support internal audits and external regulatory inspections (e.g., FDA, EMA).
14. Develop vendor assessment process and governance.
Data Integrity
15. Lead data integrity reviews, risk assessments, and remediation plans, maturity assessment
16. Provide expert guidance on secure data handling, audit trail review, user access management, and data governance.
Deviation & Change Management
17. Review and approve deviations, CAPAs, and change controls for GxP systems.
18. Conduct impact assessments and ensure effective CAPA implementation.
Training, Coaching & Continuous Improvement
19. Train teams on CSV/CSA principles, data integrity, and GxP requirements.
20. Mentor junior CSQA/CSV staff and support capability building across the organization.
Interested? For this position you’ll need the following education, experience and skills
21. Bachelor’s, master’s degree or an education in a relevant scientific discipline
22. Fluent English communication (oral and written); any additional languages are a plus.
23. A minimum of 5 to 10 years of progressive experience in the pharmaceutical industry within Quality Assurance
24. Solid experience with ERP systems in a CSV‑regulated QA environment
25. Robust and hands‑on expertise in Computer System Validation (CSV), including validation planning, execution, documentation oversight
26. Significant exposure to pre‑clinical, clinical, and post‑market environments is strongly preferred
27. A good and thorough understanding of current regulatory requirements and expectations (e.g., US, Europe, Japan, China) and an ability to interpret current regulations and requirements is essential
28. Experience in managing various GxP Inspections across geographies, including inspector facing experience
29. Should possess outstanding presentation abilities and be capable of delivering content persuasively and effectively to senior management.
30. Negotiation skills and a proven ability to influence senior leaders and others within a global matrix organization
31. Must be knowledgeable of risk analysis techniques (FMEA, …), must be able to identify and evaluate risks and propose mitigation plans within complex situations
32. Demonstrates the ability to recognize and address critical issues, with escalation to executive management as necessary
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!