Make your mark for patients
To strengthen our Internal Manufacturing Quality department, we are looking for a talented profile to fill the position of: Global QA for QC Lead - Laboratory Digital & Computerized Systems – Braine l’Alleud, Belgium.
About the role
As a QA lead within the Global QA for QC Operations team, you will serve as a strategic quality leader, driving excellence and compliance on all activities related to laboratory computerized systems, data integrity, and digital systems used within QC laboratories across UCB. This includes supporting and challenging QC teams in the selection, validation, operation, and lifecycle management of computerized systems and digital tools, while ensuring compliance with global regulatory requirements (e.g., GxP, Annex 11, 21 CFR Part 11, Data Integrity guidance). You will act as a QA partner for digitalization projects impacting QC labs, from design to deployment, ensuring robust risk assessments, adequate documentation, and sustainable implementation of compliant processes.
You will work with
You will also contribute to the harmonization of QA practices across QC sites, helping define governance, guiding validation strategy, and supporting data integrity initiatives in collaboration with IT, QC Excellence, and Data Management teams. Your leadership will directly influence global quality strategy and operational robustness, positioning UCB to meet evolving regulatory expectations and deliver on its commitment to patients worldwide.
What you will do
1. Lead QA Strategy for computerized systems and digital tools within the QC network. Define and implement robust cross-functional methodologies for managing laboratory equipment, embedding data integrity principles and regulatory compliance.
2. Ensure Global Regulatory Compliance and Inspection Readiness of Critical Laboratory Computerized Systems
Review, challenge, validate documentation (CSV) and risk assessments for major systems (Empower, LIMS, NuGenesis, SoftMaxPro). Maintain alignment with international regulations (FDA, EMA, ICH, WHO,…) and internal UCB procedures, anticipating regulatory trends and leading initiatives to sustain state of control.
3. Establish and Harmonize Data Integrity Controls
Support global QA standards and ensure consistent application across all QC laboratories and systems.
4. Act as quality representative at Governance of Computerized Systems
Partner with QC and IT teams to oversee change control, periodic reviews, access management, and incident handling for large-scale systems.
5. Act as a Key Contributor to Digital Transformation Initiatives
Provide strategic QA expertise in system implementations, upgrades, and interconnectivity projects within the QC network.
6. Promote Global Harmonization
Define and implement common QA practices for computerized systems and digital tools across all QC sites.
Interested? For this position you’ll need the following education, experience and skills
7. Scientific or technical degree (Master’s, or PhD) in Life Sciences, Engineering, Computer Science or equivalent.
8. At least 8 years of experience in the pharmaceutical or biopharma industry, including significant experience in QA, QC operations, or CSV
9. Fluent English communication (oral and written); any additional languages are a plus
10. Expertise in computerized system validation, data integrity, and GxP compliance
11. Strong working knowledge of global digital lab platforms (e.g., Empower, NuGenesis, LabWare, LIMS, SDMS).
12. Familiarity with global regulatory guidelines related to computerized systems (e.g., GAMP5, Annex 11, 21 CFR Part 11, MHRA Data Integrity).
13. Ability to manage QA activities across multiple stakeholders (QC, IT, vendors) in a matrix organization
14. Analytical, risk-based, and solution-oriented mindset with strong influencing and communication skills
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!