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

• Proactively support the operational activities of CMC and Development QA for relevant manufacturing quality systems (deviation management, change control management, complaint management, quality improvement).
• Ensure adequate QA support for environmental monitoring, qualification, validation (including cleaning) and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories.
• Ensure adequate documentation processes and systems are available and followed (SOPs, specifications, protocols, …).
• 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. Ensure and maintain the adequate accreditation for Bio Pilot Plant and Gene Therapy building.
• Drive the continuous QA improvement process ensuring that all systems and activities work in a way that ensures compliance with regulatory and corporate requirements, as well as product quality, safety and efficacy.
• Ensure that all operations are appropriately compliant with applicable regulations (EMA, FDA, etc. where relevant). Ensure an acceptable outcome of all audits and inspections, as they pertain to the Bio Pilot Plant and Gene Therapy building, equipment and facilities.

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
• 5–8 years of experience working within a pharmaceutical regulated environment, specializing in biological products
• Fluent English and French communication (oral and written); any additional languages are a plus.
• Must be knowledgeable in QA and technical requirements of pharmaceutical development processes.
• A complete 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 manufacturing, facility operation, laboratory compliance and quality systems. Areas of expertise should include compliance, quality assurance, quality control, validation, technical services, and an in-depth knowledge of at least one scientific discipline related to pharmaceutical sciences.
• Sterile parenteral and/or biological product manufacturing quality assurance experience is essential.
• 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
• Must have the ability to manage projects/activities within the area of expertise and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.

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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.