DSP Bio DS Operations Quality Specialist

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

Ensure a high level of production comprehension to know how to implement quality enhancement.

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.

Train and coach GMP Facilitators to achieve a high level of process and quality knowledge.

Quality Assurance

Ensure DSP is compliant with all UCB requirements through review and approval of GMP documentation (SOP, Master Batch record, protocols, MSAT documentation, etc.).

Perform and provide support to batch record review and release.

Propose adequate quality oversight on GMP documents and activities through QA presence on the shop floor.

Review and approve deviations, corrective and preventative actions, and change controls.

Ensure escalation of quality problems to the appropriate levels of management following the standards set by the QMS.

Regulatory Compliance

Assist in site audit and inspection readiness program.

Assist in internal and external audits.

Assist in hosting inspections or audits by regulatory authorities, UCB Global Quality Auditing team, and others as needed.

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).

Participate in reviewing Annual Product Reviews.

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

Master’s degree in Life Sciences, Engineering, Pharmacist or a related scientific field

Minimum of 5 years’ experience in the pharmaceutical industry

Fluent English & French communication (oral and written)

Knowledge of Downstream processing and cGMP environments

Experience in Quality Systems (Deviations, CAPA, Change Control, Risk Management)

Ability to drive continuous improvement and data‑based decision making

Excellent communication, collaboration and stakeholder management skills

Proven capacity to thrive in demanding and high-pressure environments

On-site presence required

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application.

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.

 

Requisition ID: 93867

Recruiter: Hiba Loutfi

Hiring Manager: Sara Schembri

Talent Partner: Sandrine Eelbo

Job Level: SA II

Please consult HRAnswers for more information on job levels.