Make your mark for patients
To strengthen our Global Quality Assurance department, we are looking for a talented profile to fill the position of :CMC Development Quality Lead – Braine l’Alleud, Belgium.
About the role
As part of the CMC Development Quality group, you will lead strategic quality management across CMC Development Sciences groups in their product and process development activities, adhering to ICH guidelines. You will ensure quality and compliance across all CMC activities, from early development to commercial launch, including clinical manufacturing, analytics, tech transfer and regulatory filings. The goal is to ensure product quality and compliance with regulatory requirements, while meeting business performance expectations.
Additionally, you will lead a sub-team within the CMC Development Quality group.
You will work with
As CMC Development Quality Lead, collaborate in a lean, efficient, and trustworthy manner with all functions involved in CMC and GMP strategic activities, including GMP/GSP Quality Operations, across the product lifecycle — covering chemical, biological, and gene therapy products — to ensure the development and manufacture of high-quality, safe, and efficacious products.
What you will do
From early development stages up to Proof of Concept (PoC) included
• Proactively provide guidance and advice to CMC Development Sciences Project Technical Solution Team (Project TST) representative members, particularly with regard to the appropriate use of UCB Quality by Design (QbD) guidelines, and interpretation of national and international cGMP regulations and ICH guidelines.
• Ensure that CMC project related Quality Assurance activities are consistent across the range of different environments and teams supported (Vendors & Strategic Suppliers / UCB in house manufacturing / UCB Partners …).
• Review and approve adequate documentation made available and followed for CMC development projects for all CMC and clinical supply related activities.
• Responsible for leading participation in partnerships with other departments to identify, mitigate and subsequently resolve compliance and quality issues that may affect UCB development activities and products.
• CMC regulatory submissions (IND/IMPD) :
o Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
o Partner with project teams to address operational deficiencies identified by regulatory Agencies.
• Actively participate in identifying, developing and implementing local quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements by encouraging others to seek opportunities for different and innovative approaches to addressing problems, developing solutions, guidance and procedure.
For product late-stage development up to commercial launch
• Ensure quality oversight on TST decisions that frame-up CMC strategy and documentation package for late-stage development.
• Coordination of and oversight on the Quality Assurance group members responsible for QA review and approval of late-stage development documents.
• Ensure progressive transfer of product and process control strategy documents to CMC Quality Lead who will ensure accountability of product quality oversight in the commercial phase.
• CMC regulatory filing activities for product registration (BLA/NDA/MAA):
o Organize and directly contribute to QA review of CMC file (development sections) prior to submission to health authorities.
o Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
o Partner with project teams to address operational deficiencies identified by regulatory Agencies.
Lead a sub-team within the CMC Development Quality group
• Coach, lead, mentor and be a referent/master for his/her team members ensuring their engagement and personal development.
• Ensure performance review and quality metric for his/her team and team members.
• Be the referent / point of contact for a specific field (New Biologic Entity, early phase)
Interested? For this position you’ll need the following education, experience and skills
• Bachelor’s or Master’s degree in a relevant scientific discipline, providing a solid foundation in biological products.
• Extensive experience within the biologic products sectors, with a strong focus on product CMC development.
• Well-versed in current Good Manufacturing Practices (cGMP) and global regulatory frameworks governing product development, including those of the United States, Europe, and Japan.
• Minimum of 8–10 years in comparable roles, demonstrating a consistent track record of leadership and technical excellence.
• Fluent in English, both written and spoken; any additional languages are a plus.
• Proven managerial experience, demonstrated ability to set strategic direction, manage performance, mentor team members, and drive cross-functional collaboration to achieve organizational goals.
• Recognized for inspiring confidence through a combination of technical expertise and strong influencing skills, particularly within Chemistry, Manufacturing, and Controls (CMC) development settings
• Skilled in delivering clear, impactful presentations to diverse, multicultural, and interdepartmental audiences.
• Adept at navigating complex and ambiguous issues, contributing to sound, evidence-based decision-making processes.
• Excellent interpersonal, verbal, and written communication abilities, with a talent for engaging stakeholders at all levels.
• Fact-based decision maker: Capable of understanding complex issues and contributing to informed decision-making, particularly when dealing with ambiguous or “grey” areas
• Highly organized with strong analytical capabilities, enabling thorough evaluation of data and informed decision-making.
• Acts as a facilitator and strategic planner, capable of influencing outcomes and aligning cross-functional objectives.
• Experienced in coordinating initiatives with mid-to-senior level management, as well as external partners and stakeholders.
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 around 8,500 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.
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 EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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