Bio DS Operations Quality Manager Weekend

Bio DS Operations Quality Manager Weekend – Braine l’Alleud, Belgium

To strengthen our Bio DS Quality we are looking for a talented profile to fill the position of: Bio DS Operations Quality Manager Weekend – Braine l’Alleud, Belgium

About The Role

You will ensure the quality oversight of activities specifically related to upstream (USP), downstream (DSP) and Media & Buffer (M&B) 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 of the operational quality team on the floor, ensuring quality systems (Deviation, CAPA, CC) are followed and ensuring batches are released. The Bio DS Operations Quality Manager ensure 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

In this role, you will collaborate closely with manufacturing teams operating the biologics production process (USP, DSP, and Media & Buffer), while leading and coaching a team of GMP Facilitators. You will work in partnership with colleagues from Quality Assurance, Quality Control, MSAT, Regulatory Affairs, and other site quality leaders to ensure manufacturing activities remain compliant, batches are released on time, and quality issues are resolved efficiently. As the weekend quality lead, you will also play a key role in connecting weekend and weekday teams to ensure seamless communication and consistent quality standards across the site.

What You Will Do

Leadership and Management

• Build, lead and manage the Weekend 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 manufacturing operations by GMP Facilitators.
• Ensure a constant alignment with QA peers to provide a consistent quality support.
• Ensure a consistent approach to team management, performance follow‑up, and employee development across the USP, DSP, and M&B organizations, in alignment with weekday teams and site expectations.
• 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 MSAT process improvement.
• Propose solutions on major and critical issues encountered in USP, DSP and M&B manufacturing.
• Influence on way of working of other local department.

Quality Assurance

• Responsible for the effective management of quality systems, 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 batch review process and intermediate batch release process.
• Ensure all Process Orders (POs) related to 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 manufacturing activities.
• Review and approve major or critical deviations, CAPA and Change Control.
• Actively participate to the quality governance in place within the organization.
• Ensure consistency in the management and resolution of quality events across weekend and weekday teams.
• Act as a key liaison between weekend and weekday organizations to guarantee effective communication, escalation, and transfer of quality-related information.
• Support the implementation of quality improvements by ensuring alignment of practices, lessons learned, and decisions across all shifts and teams.

Regulatory Compliance

• Performs internal inspections.
• Assist and / or explain topics related to USP, DSP and M&B activities if requested during an internal or external inspection.
• Ensure critical / major risks related to inspection readiness are appropriately escalated. Ensure rel