Make your mark for patients
To strengthen our Bio DS Quality, we are looking for a talented profile to fill the position of: DSP Bio DS Operations Quality Specialist – Braine l’Alleud, Belgium
About the role
The DSP Bio DS Operations Quality Specialist will ensure the quality oversight of activities related to Downstream (DSP) manufacturing operations within UCB’s new commercial biologicals drug substance facility at our Braine campus.
This role is crucial in ensuring compliance with regulatory and internal standards, ensuring a continuous presence on the floor and ensuring quality systems (Deviation, CAPA, CC) are followed. The DSP Bio DS Operations Quality Specialist ensures that all these activities are performed in a solution-oriented mindset.
As this is a new facility, the role requires adapting to the challenges and realities of the initial years of operations. Additionally, this role involves connecting to peers (production, engineering and quality) within B7 and UCB organization to ensure knowledge sharing and to build a solid network.
You will work with
You will collaborate with Production, Engineering, MSAT, Quality and site leadership teams to ensure operational excellence and GMP compliance. The role also involves regular interaction with regulatory authorities and global quality stakeholders to support inspections, audits, and continuous improvement initiatives.
You will work at the intersection of Quality and Operations, collaborating closely with DSP production team, QA Supervisor and GMP Facilitators. As a key partner to both operational and quality teams, you will help ensure compliant manufacturing processes, support issue resolution, participate in batch release, and contribute to process continuous improvement.
What you will do
Expertise
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Ensure a high level of production comprehension to know how to implement quality enhancement.
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Participate on the facility Quality Operational Team meetings and share production knowledge.
- Highlight main production quality challenges, propose and implement actions to improve practice on the floor and process.
- Ensure all deviations, CAPA and change control are summarized shared to the quality team.
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Train and coach GMP Facilitators to achieve a high level of process and quality knowledge.
Quality Assurance
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Ensure DSP is compliant with all UCB requirements through review and approval of GMP documentation (SOP, Master Batch record, protocols, MSAT documentation, etc.).
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Perform and provide support to batch record review and release.
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Propose adequate quality oversight on GMP documents and activities through QA presence on the shop floor.
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Review and approve deviations, corrective and preventative actions, and change controls.
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Ensure escalation of quality problems to the appropriate levels of management following the standards set by the QMS.
Regulatory Compliance
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Assist in site audit and inspection readiness program.
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Assist in internal and external audits.
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Assist in hosting inspections or audits by regulatory authorities, UCB Global Quality Auditing team, and others as needed.
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Ensure critical / major risks related to inspection readiness for DSP activities are appropriately escalated. Ensure relevant mitigations and documentation are available (e.g., power point presentation, preventive actions).
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Participate in reviewing Annual Product Reviews.
Interested? For this position you’ll need the following education, experience and skills
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Master’s degree in Life Sciences, Engineering, Pharmacist or a related scientific field
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Minimum of 5 years’ experience in the pharmaceutical industry
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Fluent English & French communication (oral and written)
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Knowledge of Downstream processing and cGMP environments
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Experience in Quality Systems (Deviations, CAPA, Change Control, Risk Management)
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Ability to drive continuous improvement and data‑based decision making
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Excellent communication, collaboration and stakeholder management skills
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Proven capacity to thrive in demanding and high-pressure environments
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On-site presence required
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.
