Media, Buffer

To strengthen our Bio DS Quality we are looking for a talented profile to fill the position of: Media, Buffer & Logistics (MBL) Bio DS Operations Quality Manager – Braine l’Alleud, Belgium.

About The Role

The Media, Buffer & Logistics (MBL) Bio DS Operations Quality Manager will ensure the quality oversight of activities specifically related to media, buffer preparation, storage and local logistics 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 of the MBL quality team on the floor, ensuring quality systems (Deviation, CAPA, CC) are followed and ensuring supply reliability. The MBL Bio DS Operations Quality Manager ensures that all these activities are performed in a solution-oriented mindset.

As this is a new facility, the role requires actively leading and coaching the team through the launch phase, adapting to the challenges and realities of the initial years of operation. Additionally, this role involves connecting to peers (business and quality) within B7 and UCB organization to ensure knowledge sharing and to build a solid network.

You will work with

You will work at the intersection of Quality and Operations, collaborating closely with Media, Buffer & Logistics teams, GMP Facilitators, Manufacturing and fellow Quality leaders. As a key partner to both operational and quality teams, you will help ensure compliant manufacturing processes, support issue resolution, oversee batch releases, and contribute to continuous improvement and inspection readiness across the site.

What You Will Do

Leadership and Management:

• Build, lead and manage the MBL Quality Operations team, including hiring, training, and performance management.
• Develop people capability & knowledge. e.g: by implementing training matrix and coaching for GMP Facilitators.
• Ensure day-to-day quality oversight of the operations by GMP Facilitators.
• Ensure a constant alignment with QA peers to provide a consistent quality support.
• Perform continuous feedback within Quality Operations team and with Manufacturing counterparts.
• Participate on the Bio DS Quality Operations Lead Team and act as deputy for Bio DS Quality Operations Head when needed.
• Participate on regular alignment meeting with local and Global business partners (i.e., Manufacturing, MSAT, Quality Assurance Support, Quality Control, Regulatory)
• Be part of/Challenge all MBL MSAT process improvement.
• Propose solutions on major and critical issues encountered in MBL manufacturing.
• Influence on way of working of other local department.

Quality Assurance

• Responsible for the effective management of quality systems operating in MBL scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Guarantee appropriately assessed from a quality perspective and are closed in time.
• Responsible for the effective and right-first-time MB batch review process and MB intermediate batch release process.
• Ensure all Process Orders (POs) related to MB manufacturing activities are released.
• Organize thorough review / approval of GMP documentation and their appropriate application (e.g., gembas, spot checks, shopfloor).
• Ensure quality representatives are involved in case of significant events occurring during MBL manufacturing activities.
• Review and approve major or critical deviations, CAPA and Change Control.
• Actively participate to the quality governance in place within the organization.
• Support new product introductions in MBL production.

Regulatory Compliance

• Performs internal inspections related to MBL activities.
• Assist and / or explain topics related to MBL activities if requested during an internal or external inspection.
• Ensure critical / major risks related to inspection readiness for MBL 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

• Bachelor’s, master’s degree or an education in a relevant scientific discipline
• Minimum of 5 years’ experience in the pharmaceutical industry
• Fluent English & French communication (oral and written).
• Proven experience in logistics within a regulated pharmaceutical environment
• Prior people management experience is considered a strong asset
• Experience with SAP and a strong understanding of its functionalities are essential
• Ability to collaborate and influence across d