Make your mark for patients
To strengthen our CMC 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 Analytical and 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 analytical expertise for supporting, reviewing and approving controlled documents (global analytical methods, Global Specification, Product Stability Strategy, Annual Stability Plan, …) or CMC sections linked to regulatory submissions.
· Provide support to CMC Quality Leads for product risk management.
Transversal 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.
· Be the CMC Quality department representative member at the QMS Team or assigned upon request to one 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.
· Exercise sound judgment based on a thorough understanding of the business and industry.
· 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.
· Skilled in operating in a multi-cultural environment.
· 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!