CMC Quality Solutions Partner

il y a 2 semaines


Brainel'Alleud, Belgique WhatJobs Temps plein

Make your mark for patients To strengthen ourCMC Quality department, we are looking for a talented profile to fill the position of:CMC Quality Solutions Partner – Braine l’Alleud, Belgium About the role As part of the CMC Quality Organization and reporting to the Head of CMC Quality Solutions, this position provides GMP-quality expertise to drive continuous improvement in Quality Assurance (QA), facilitate problem-solving, and ensure effective use of the Quality Management System (QMS). The role supports CMC Quality activities by promoting robustness, efficiency, alignment, and a standardized approach across the CMC Quality Lead and CMC Quality Solutions teams. Additionally, it brings scientific and QA expertise to strategic QA activities related to the lifecycle management of commercially available products or those in late-stage development—including regulatory submissions, product launches, improvements, and phase-out—ensuring the delivery of high-quality, safe, and effective products to market. You will work with This role requires close collaboration and partnership with various functions within UCB’s Quality Organization, including the Quality Systems team, External & Development Supply Quality, Internal Manufacturing Quality, Distribution and Market Quality, and Devices, Primary Packaging & DHT Quality. In addition, they involve cross-functional interaction with teams such as Patient Impact, Patient Evidence, Patient Solutions, Global Regulatory Affairs, Safety, Patient Supply, and other internal UCB stakeholders. What you will do Provide support across the Products portfolio Provide scientific and technical expertise to support, review and approve controlled documents across CMC domains, including but not limited to drug substance, drug product, finished product and other relevant areas contributing to regulatory submissions Provide support to CMC Quality Leads in product risk management, regulatory inspections and customer audits and oversight of key quality activities including change control and complaint committees, product recalls and escalations, product manufacturing flows, product metrics, SOPs and control documents, product QA knowledge (i.e. Product(s) SharePoint(s)), CMC sections, product launches, annual reports, and Yearly Biological Product Reports Transversal Activities, Projects and Initiatives Drive or support assignments for projects affecting more than one product or for process improvement related to the CMC Quality Lead core activities, ensuring the continuous improvement process works in a harmonized and transversal (cross-products) way, operates in a fit for purpose and in a smarter way and delivers business performance Represent the CMC Quality department when designated to a quality system process Lead the creation of simplified, efficient, harmonized processes and procedures to support the team’s activities Ensure effective communication and coordination of activities when shared across teams in different areas of UCB Upon request, take delegation from the Head of CMC Quality Solutions for special assignment. 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 5 years in pharmaceutical/biologics quality management. Operational experience in GMP (Quality, Manufacturing, or Quality Control) is a plus Fluent English communication (oral and written); any additional languages are a plus Strong understanding of global pharmaceutical regulations and industry practices from both business and technical perspectives. Ability to independently analyze data, draw conclusions, and make effective decisions. Identify and suggest opportunities for harmonization and synergies across global products. Assess risks and propose corrective actions within areas of expertise. Manage complex and stressful situations by breaking them into manageable tasks, respecting deadlines. Experience in GMP audits and inspections, project management, data integrity assessment, and understanding of CMC regulatory requirements are all strong assets. Capable of working independently with limited supervision. Adapt to different products, tasks, and Quality Leads with a collaborative mindset. Deliver presentations and reports at executive management level with proficiency and confidence. 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 Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel. #J-18808-Ljbffr


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