Make your mark for patients
To strengthen our Quality Intenral Manufacturing Operations department we are looking for a talented profile to fill the position of: QA Systems Lead – Braine l’Alleud, Belgium.
About the role
You will ensure that all technical operations involved in the production and analysis of pharmaceutical products strictly comply with applicable regulations, guidelines, and internal corporate policies, while contributing to the development and implementation of robust, compliant systems that support, monitor, and continuously improve operations. You will establish and sustain a strong state of compliance and control by proactively driving quality improvements in response to business, technical, and regulatory changes, and by leading continuous improvement initiatives aimed at reducing risk, enhancing key quality performance indicators, and maintaining high product quality.
You will work with
You will work with cross-functional stakeholders across the organization, including production, quality assurance, quality control, regulatory affairs and technical teams, as well as corporate functions responsible for compliance and governance. It also collaborates with external partners, inspectors, and regulatory authorities to ensure alignment with industry standards. Through these interactions, you will act as a key link between operations, quality, and business units, supporting the consistent delivery of compliant, high-quality pharmaceutical products while driving continuous improvement initiatives.
What you will do
General QA Role
1. Promote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teams
2. Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements
3. Maintaining and continuously improving the Quality Management System and related processes.
4. Ensuring continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects.
Documentation Management Processes, Systems and Operations
5. Support Internal Manufacturing organization in establishing effective and efficient Document Management System and electronic Content Management System (eCMS) (serving both local & global needs) and related processes.
6. Maintain and continuously improve the Document Management System eCMS and related processes, both local and global.
7. Management of Deviation, Investigation and CAPA related to local Documentation Management activities.
Training Management Processes, Systems and Operations
8. Support Technical Operations organization in establishing effective and efficient Learning Management Systems (LMS & eLMS) (serving both local & global needs) and related processes. Maintain and continuously improve the LMS/eLMS and related processes, both local and global.
9. Ensure adequate coaching and training of all relevant stakeholders to ensure:
10. optimized effectivity of cGMP documentation (readability)
11. optimized effectivity of Documentation Lifecycle Management Processes
12. optimized effectivity of workforce Training & Education through coaching on Good Practices (promote use of certification & coaching Programs and classroom training on critical activities)
13. Training Booster
14. Management of Deviation, Investigation and CAPA related to local Training Management activities.
Sample Management Processes, Systems and Operations
15. Assure that the Sample Management operate in accordance with the regulatory requirements
16. Management of Deviation, Investigation and CAPA related to Sample Management activities.
Continuous Improvement
17. Drive the identification of opportunities or improvements
18. Develop, drive and/or implement quality improvement and operational excellence projects in response to business requirements, observed issues, technical changes, identified risks, audit observations and changing regulatory requirements
19. Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP
Digitalization
20. Participation to Digitalization Improvement Programs.
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 & French communication (oral and written); any additional languages are a plus.
23. Experience in a regulated pharmaceutical environment OR other life science OR health related fields is mandatory.
24. Experience in Quality & Compliance and worldwide regulations pertaining to cGMP regulations is required.
25. Experience with Quality Management Systems and Auditing is an asset.
26. Experience in managing and leading teams is considered an advantage.
27. Very good command in French AND English (both written and spoken).
28. Ability to balance multiple priorities.
29. Fact based decision maker with accountability.
30. Team player with good interpersonal relationship and communication skills.
31. Able to independently identify problem situations and initiating problem solving.
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!