Media, Buffer & Logistics (MBL) Bio DS Operations Quality Manager
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Full-time
bachelor degree, postgraduate degree
Supportive culture, Equal opportunities, Career growth opportunities, Hybrid work environment
Posted 9d ago
~40 hrs/week
Responsibilities
The MBL Bio DS Operations Quality Manager will lead the quality oversight of media, buffer preparation, and logistics within the biologicals drug substance facility. This role involves managing quality systems, ensuring regulatory compliance, and coaching the team through the launch phase of the new facility.
Requirements
Candidates must hold a bachelor's or master's degree in a relevant scientific discipline and possess at least 5 years of experience in the pharmaceutical industry. Proficiency in English and French, along with experience in logistics and SAP, is essential for this position.
Full job description
Make your mark for patients
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 departments and levels
On-site presence required
Demonstrated experience in audit and inspection
Ability to face unstable environment and demonstrate agility to handle unpredicted changes
Ability to work effectively under pressure and adapt to changing priorities
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 [email protected] . Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 93800
Recruiter: Hiba Loutfi
Hiring Manager: Mathieu Marrot
Talent Partner: Sandrine Eelbo
Job Level: MM II
Please consult HRAnswers for more information on job levels.
Related keywords
Bio DSMediaBufferLogisticsQuality AssuranceGMPDeviationCAPAChange ControlBatch ReleaseSAPMSATRegulatory ComplianceInspection ReadinessAnnual Product ReviewBiopharmaceutical
We’re #TeamUCB, a global biopharmaceutical company. 💙 Inspired by patients 🔬 Driven by science
Industry
Pharmaceutical Manufacturing
Company size
5,001-10,000 employees
Founded
1928
Headquarters
Brussels
LinkedIn followers
358,893
Total funding
$202M
At UCB, we believe everyone deserves to live the best life they can - as free as possible from the challenges and uncertainty of disease. Our purpose is to support people living with severe central nervous system and immunological conditions by delivering meaningful solutions that go beyond medicine.
We are driven by the experiences of patients and caregivers, and inspired to pursue innovations that create real value - not just in clinical outcomes, but in everyday moments, dreams pursued, and simple pleasures enjoyed. Our ambition is to unlock transformative science and technologies that respond to unmet needs and elevate lives.
From our headquarters in Belgium to nearly 40 countries around the world, we nurture a culture of respect and care. By listening deeply and collaborating across borders and disciplines, we enable cutting-edge research shaped by patients’ needs. Through strong connections with healthcare professionals, partners, and communities, we strive to make a lasting impact - today and into the future.
We're inspired by patients, driven by science.
Offices: Allée de la Recherche, 60, Brussels, BE · 1950 Lake Park Drive, Smyrna, Georgia 30080, US · 8010 Arco Corporate Drive, Raleigh, North Carolina 27617, US · 208 Bath Road, Slough, SL1 3WE, GB · Chemin du Foriest, B - 1420 Braine-l'Alleud, BE
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