GMP Process and Operations Compliance Specialist

Make your mark for patients

We are looking for a GMP Process and Operations Compliance Specialist who is quality-driven, proactive, and collaborative to join us in our Clinical Manufacturing Compliance and Excellence team, based in Braine-L’Alleud, Belgium.

About the role 
You will help ensure a compliant, high-quality manufacturing environment for clinical products, with a primary focus on the biologics pilot plant and support to the new chemical entities pilot plant. You will partner with manufacturing and support teams to strengthen operational compliance, drive effective issue management, and embed continuous improvement. Your work will help protect product quality, patient supply, and a safe workplace culture.

Who you’ll work with
You will be working in a team that supports manufacturing across pilot plant facilities and collaborates closely with production, process engineering, supply, and quality partners. Together, you will promote consistent compliance practices, share insights from the shop floor, and improve ways of working through practical, data-informed actions.

What you’ll do 

• You will embed operational compliance through daily management routines, issue management, and practical continuous improvement with production, engineering, and supply teams. 


• You will oversee key operations compliance (e.g.  line clearance  , material conformity, equipment (cleaning) status, media simulation and operators certification/qualification.


• You will lead deviation management, investigations, root cause analysis, and change control ownership, including defining corrective and preventive action plans with subject experts.


• You will act as a trainer/coach, Power User on root cause analysis and ensuring control & improvement related to Dev and CC Process through quality tier meetings supported by up-to- date KPIs.


• You will identify and own operational risks linked to processes, operations, and equipment, ensuring risk documentation is accurate and up to date.


• You will support readiness activities such as audits and shop-floor compliance walks


• You will contribute to quality forums by highlighting key topics, trendsand follow-up actions.

Interested? 

For this role we’re looking for the following education, experience and skills

• Bachelor’s degree in a science field, with at least five years’ experience in a regulated pharmaceutical environment. 


• Experience in biomanufacturing or quality roles, with hands-on knowledge of process and operations compliance requirements.


• Proven experience managing deviations, investigations, root cause analysis, and change control in regulated operations.


• Understanding of compliance expectations for low-bioburden biologics environments and/or sterile manufacturing environments.


• Able to prioritise multiple topics, work autonomously while partnering effectively, and drive practical improvements that increase compliance and efficiency.


• Fluent French with good written and spoken English communication skills.

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.