Qualification and Validation Lead (Belgium)

Make your mark for patients

We are looking for a Qualification and Validation Lead who is collaborative, rigorous and proactive to join us in our BioNexUS Internal Manufacturing team, based in our UCB campus in Braine-l’Alleud, Belgium.

About the role

This role is part of the BioNexUS project, contributing to the design and delivery of a future-ready biologics manufacturing facility. You will ensure that manufacturing systems, equipment and processes are designed and delivered in compliance with regulatory and quality requirements. You will contribute to building a compliant and inspection-ready facility by integrating validation principles throughout the project lifecycle in a rapidly evolving project environment.

Who you’ll work with

You will be working in a team that collaborates with manufacturing sites, quality experts and project stakeholders. The team focuses on ensuring compliance, alignment with regulatory expectations and readiness for inspections working across different time zones.

What you’ll do

Develop, implement, and lead the overall Qualification and Validation strategy for the entire site, while ensuring its successful execution and ongoing compliance across all operations.

Define and represent qualification and validation requirements across the project.

Ensure compliance with regulatory and quality standards throughout design and delivery.

Review and assess technical documentation related to validation activities.

Contribute to inspection readiness and support audit and regulatory interactions.

Translate operational and regulatory expectations into project requirements.

Promote strong quality and compliance culture across stakeholders.

Interested? For this role we’re looking for the following education, experience and skills

More than 10 years of relevant experience in qualification and validation within regulated environments.

Experience in greenfield or brownfield projects.

Experience in biotech is mandatory.

Knowledge of GMP requirements and regulatory expectations.

Experience supporting audits and regulatory inspections.

Strong ability to analyse and interpret technical documentation.

Strong communication and collaboration skills.

Willingness to adapt to project variabilities and a rapidly evolving work environment.

Fluent in English; French is an advantage.

Occasional travel to the United States may be required during conceptual design and basic design phases.

Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.

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, this role is hybrid with 40% of your time spent in the office, irrespective of your current contractual agreement. Should your current working arrangements differ, please contact your Talent Partner to discuss, before submitting your application.

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.

 

Requisition ID: 93242

Recruiter: Flore Bourlet

Hiring Manager: Nicolas TIECHE

Talent Partner: Joelle Coldrick

Job Level: MM I

Please consult HRAnswers for more information on job levels.