Make your mark for patients
To strengthen our Clinical Manufacturing Quality department, we are looking for a talented profile to fill the position of: Clinical Manufacturing Supply Quality Lead – Braine l’Alleud, Belgium.
About the role
The Clinical Manufacturing Supply Quality Partner is responsible for establishing, implementing, maintaining, and continuously improving an effective Level of Quality linked to the supply chain and logistic activities on the Braine-l'Alleud site. Moreover, you will be optimizing processes, releasing incoming GMP materials, monitoring KPIs, driving continuous quality and operational improvements, and partnering with stakeholders to assess and resolve deviations, investigations, and other quality issues related to supply and logistics.
You will work with
As a Clinical Manufacturing Supply Quality Lead you will collaborate closely with the Clinical Manufacturing Supply and Logistics teams to align material flows and warehouse operations with quality requirements. You will also work regularly with supply teams to ensure timely release of incoming materials, and with Quality colleagues and other cross‑functional stakeholders to manage deviations, investigations, KPIs, and continuous improvement initiatives related to supply and logistics.
What you will do
General
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Ensuring the material supplied to the development manufacturing areas are purchased, received, stored and according to the Good Distribution Practices and the applicable temperature and storage conditions and that they comply with the applicable specifications and are released according to the cGMP and applicable regulations.
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Treating alignment of quality related issues and follow up on the corrective and preventive actions (via the handling of deviations, out of specifications, investigations, change controls, audit findings…)
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Setting up, reviewing and approving procedural documents related to these activities.
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Performing continuous GAP analysis between regulatory framework / new expectations and Development QMS and between UCB documentation and actual practice
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In response to business requirements, identifying, treating and as appropriate escalating, the potential issues of non-cGMP/GDP compliance and provide QA expertise, interpretation and direction to create a framework of operational excellence and continuous improvement.
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As SAP User, provide cGMP and QA expertise, interpretation and direction on SAP system enabling implementation of continuous improvement regarding specific domain of knowledge
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As QA representative, supporting audits regarding specific domain of knowledge (SAP Master Data, incoming release, warehouse management, ...)
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Partnering with the project teams to address operational deficiencies identified by regulatory Agencies.
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Ensure the supply and logistic activities stay compliant with:
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Principles of good Distribution Practices as required in Directive 2001/83/EC
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EC GMP guidelines (EudraLex - The Rules Governing Medicinal Products in the European Union, volume 4 – last edition)
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Clinical Trials Regulation EU No 536/2014
Supply
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Reviewing and approving the incoming material specifications and FIP (Individual Sampling Form) for raw materials and consumables.
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Supporting to Maintain up-to-date TSE/BSE statements for all relevant materials.
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Contributing to assessing the Pharmacopeias’ & the supplier’s Change Notifications and implementing the change controls to review all the material related documentation (specification, sampling requirement,…).
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Closely collaborating with the QA team in charge for supplier/vendor management.
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Ensuring the release of GMP incoming goods in a timely manner, to support the development manufacturing activities.
Logistics
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Planning and managing compliance tours and on the floor spot-check of the warehouse areas, offering quality assurance support including but not limited to inspection.
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Identifying and facilitating resolution of logistic quality issues that may impact on the quality of the CMC sections of regulatory submissions.
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Ensuring the cold chain and controlled temperature process are in place and implemented according to the GDP.
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Contributing to the effective management of “end-of-life” inventory by ensuring the blocked stock material is promptly disposed of or, where applicable and at the request of the business stakeholder, by transferring the related high-value-added inventory to “technical” status.
Interested? For this position you’ll need the following education, experience and skills
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Bachelor’s or master’s degree or an education in a relevant scientific discipline
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Extensive experience in pharmaceutical regulated environment.
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Solid background in QA/GMP and technical requirements of pharmaceutical warehousing activities (GDP) and on analytical requirements and methods of the European and US pharmacopeia’s
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Holding a Belgium QP number offers a significant advantage
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QA/compliance experience in supply, logistics, quality management and quality control.
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Fluent English and French communication (oral and written)
- Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
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Ability of effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
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Stress resistant; able to make quality/compliance decisions in a business environment.
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Ability to independently analyze data and information to draw conclusions and make effective decisions.
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.
