Make your mark for patients
To strengthen our Clinical Manufacturing Quality department, we are looking for a talented profile to fill the position of: Manufacturing Systems Quality Partner – Braine l’Alleud, Belgium.
About the role
As a Manufacturing Systems Quality Partner, you will be part of the “Internal Bio & GT Manufacturing Systems Quality team”, and you will be responsible for supporting the manufacturing activities of the Bio Pilot Plant (T2 building) and the Gene Therapy building (Genesis - T4) based in Braine.
You will work with
This role collaborates closely with development scientists, CMC and operations teams, and technical services to support daily manufacturing, validation, and qualification activities. It also works with QA colleagues, auditors, and senior management to manage deviations, change controls, inspections, and maintain compliance across the Bio Pilot Plant and Gene Therapy facilities.
What you will do
1. Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
2. Participate in the continuous QA improvement process. Ensure adequate documentation is available and followed for development projects (SOPs / Protocols / Report review…)
3. Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
4. Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specification) that may affect UCB development activities and products.
5. Support Change Control and perform the QA evaluation
6. Provide quality support for qualification and validation activities related to Clinical Manufacturing activities
7. Ensure KPI (including extracts) are adequately maintained and Shared.
Interested? For this position you’ll need the following education, experience and skills
8. Bachelor’s, master’s degree or an education in a relevant scientific discipline
9. A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
10. QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is an asset.
11. Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
12. Understands practical applications of GMP, compliance principles and theories including risk management
13. Good written/oral communication in English is an asset
14. Ability to work autonomously for the assigned activities with limited supervision
15. Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
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!