Genesis Quality Lead

Make your mark for patients

To strengthen our External and Clinical Supply Quality we are looking for a talented profile to fill the position of: Genesis Quality Lead – Braine l’Alleud, Belgium.

About the role

The Genesis Quality Lead will play a key role in supporting the construction and qualification of a new facility by providing GxP Quality Assurance support throughout the project lifecycle. The role is responsible for ensuring the new building complies with all applicable regulatory requirements and UCB quality standards, from the User Requirements Specification (URS) phase through to Go-Live. In addition, the Genesis Quality Lead will ensure that the Gene Therapy Quality Management System is appropriately established and implemented for all project activities, while driving inspection readiness and being accountable the certification process of the new facility.

You will work with

You will work closely with a broad range of stakeholders across Quality, Engineering, Validation, Manufacturing, Regulatory Affairs, and Project Management to ensure the successful delivery of the Genesis facility. As a member of the project Leadership Team, you will collaborate with the End-to-End Project Leader, lead and support the project Quality team, partner with Quality Management System experts and Gene Therapy Quality Leads, and engage with vendors, external partners, and Health Authorities. You will also work cross-functionally with teams responsible for equipment qualification, computerized systems, automation, process development, laboratory operations, training, and site integration activities to ensure the new facility is compliant, inspection-ready, and successfully embedded within the Braine site operations.

What you will do

• To be an active member of the project Leadership team (dotted line with the project E2E leader).
• To lead and support the project Quality team, ensuring appropriate resources are assigned, priorities are addressed and decisions and deliverables provided in a timely manner
• to ensure that the final plant and as applicable the analytical and process development temporary laboratories, its/their equipment, flows, and processes will be compliant to EU and FDA cGMP and UCB standards (including GSP).
• to ensure that any significant GMP and regulatory risks are appropriately mitigated and/or escalated to management.
• to ensure that a phase-appropriate and risk-based quality management system is in place, always applied and fit for purpose at all times of the project. In particular to:

• • • review and approve verification strategy as per ASTM E2500 and ensure that this strategy is applied in an appropriate manner.
    • ensure that the procedures and tools that will be required to deploy a lean and efficient verification approach (ASTM E2500) for the entire project are in place in a timely manner.
    • ensure that the required specific verification procedures are in place to ensure compliant C&V activities.
    • ensure that the training plans are defined in a phase appropriate manner and implemented.
    • ensure adequate support and expertise is provided to reach compliance and regulatory expectations in the field of validation of electronics/computerized systems and automation, including the implementation of new technology innovation and facilities and support to external parties where required.

• • to ensure appropriate Vendor qualification.
  • to ensure that all Audits, Inspections, Vendor Qualification, Verification, and other QA activities are integrated in the overall project schedule, as defined in the project QMS.
  • to ensure appropriate communication with Health Authorities on the project.
  • to ensure that appropriate GLP (as needed) and GMP documentation is ready to obtain GLP and GMP clinical manufacturing authorizations in a timely manner with the competent relevant authorities:

• this will include as appropriate authoring, reviewing and/or approval of SOPs, as well as review and/or approval of related deviations, change controls and Verification deliverables.

• • to actively support all projects activities as required.
  • to develop jointly with the Quality Management System and/or other GT Quality Leads a compliant, fit-for-purpose, Quality Management System supporting for the Genesis building.
  • to lead appropriate QA integration activities and participate to the other workstreams to ensure Genesis activities are embedded on time in the Braine site.

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
• Fluent English communication (oral and written); any additional languages are a plus.
• Minimum 10 years in biotech operational quality and/or qualification senior position.
• Proven involvement in significant major biotech/engineering projects.
• Strong knowledge of cGMP and HA regulations.
• Strong knowledge of ASTM E2500 verification concept is an asset.

• Gene therapy experience is a strong advantage.
• Ability to inspire, motivate and lead a team.
• Ability to work in highly dynamic environment and to handle challenging situations.
• Excellent communication skills (leadership, negotiation, change management, facilitation).
• Decision making ability and high sense of responsibility.
• Ability to influence, challenge and argument.
• Ready to travel a limited period of time.

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 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.