Manufacturing Systems Quality Partner

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 

• 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.


• Participate in the continuous QA improvement process. Ensure adequate documentation is available and followed for development projects (SOPs / Protocols / Report review…)


• 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.


• 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.


• Support Change Control and perform the QA evaluation


• Provide quality support for qualification and validation activities related to Clinical Manufacturing activities


• Ensure KPI (including extracts) are adequately maintained and Shared.

Interested? For this position you’ll need the following education, experience and skills

• Bachelor’s, master’s degree or an education in a relevant scientific discipline


• 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.


• QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is an asset.


• Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business


• Understands practical applications of GMP, compliance principles and theories including risk management


• Good written/oral communication in English is an asset


• Ability to work autonomously for the assigned activities with limited supervision


• 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! 

About us 
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are over 9.000 people in all four corners of the globe, inspired by patients and driven by science. 

Why work with us? 
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential. 

At UCB, we’ve embraced a hybrid-first approach to work, bringing teams together in local hubs to foster collaborative curiosity. Unless expressly stated in the description or precluded by the nature of the position, roles are hybrid with 40% of your time spent in the office.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. 
 
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.