Make your mark for patients
To strengthen our Global Quality Assurance department, we are looking for a talented profile to fill the position of: Quality Process Data Owner - Source Quality– Braine l’Alleud, Belgium
About the role
In this role, you will lead the strategy, governance, and continuous improvement of UCB’s global digital quality systems. You will drive harmonized quality processes across the organization, guide and mentor the support team, and collaborate closely with IT and business partners to ensure seamless system integrations. You will also oversee key projects within Veeva Vault (Source), optimizing compliance, efficiency, and data integrity across our eQMS platform.
You will work with
You will partner with Development Solutions teams and key system owners to ensure smooth integrations between Veeva Vault (Source) and other enterprise platforms, aligning data models, simplifying workflows and enabling seamless end‑to‑end quality processes across the organization.
What you will do
1. Provide stewardship and functional management to lead the implementation of strategies for all UCB’s GxP and non-GxP QA processes.
2. Act as the process data owner for Veeva Vaults.
3. Ensure the complete global rollout and use of the platform in collaboration with other Quality groups and applicable business areas. Ensure the platform is maintained in a compliant state (validation, current procedures, etc.).
4. Ensure that new guidelines and regulations relating to the management of documents controlled in the pharmaceutical industry are reviewed and monitored.
5. Provide competent and accessible support/consultancy to all pharmaceutical regulated areas regarding best documentation practices. Take a leadership role in bringing together the content management and quality system community on a periodic basis.
6. Be accountable for the inspection and audit readiness of the platform under the scope of the Quality Innovation & Strategic Planning team.
7. Drive long‑term strategic planning for platforms under the scope of the Quality Innovation & Strategic Planning team in collaboration with stakeholders.
8. Proactively seek continuous improvement and develop/share best‑practice solutions and processes related to organization, positive attitude, harmonized work style, and customer focus.
9. Support other areas of the organization (in the spirit of helpfulness and generosity) according to their needs.
10. Establish and build a network with UCB key stakeholders and external partners in relation to Quality Systems.
11. Coach and lead a team of business support professionals by providing leadership, senior expert advice, support, and management for daily maintenance operations of the platform under the scope of the Quality Innovation & Strategic Planning team.
12. Write, review and/or approve—when appropriate—SOPs, Change Controls, Complaints, Deviations, Investigations, and/or CAPAs as they relate to the computerized system in scope.
13. Act as a facilitator and contributor for the definition of global communication needs for the various owned systems.
14. Develop, implement, and continuously enhance Veeva Connections for Source Quality.
Interested? For this position you’ll need the following education, experience and skills
15. Bachelor’s degree or an education in a relevant scientific discipline
16. At least 5 years’ of experience in administration or maintenance of electronic document management or comparable electronic tools (preferably in the biosciences or pharmaceutical industry)
17. Fluent English communication (oral and written); any additional languages are a plus
18. Knowledge of GxP principles of the ICH Guidelines and FDA regulations.
19. Good knowledge of validation requirements for computerized systems in the pharmaceutical environment
20. Project management skills and experience
21. Excellent influencing and leadership skills particularly within multi-cultural and virtual environments
22. Must be competent in driving cross-functional projects
23. Ability to coach staff and colleagues through effective problem solving to ensure the best resolution is obtained.
24. Excellent ability to analyze information, take initiative and strive for lean processes, efficient and effective training and thus enhance quality, performance, and compliance.
25. Complex problem-solving, very creative personality with the talent to clearly communicate and develop strong networking.
26. Identifies and assesses risks and proposes corrective actions in unusual situations.
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!