QA Qualification & Validation Lead

仕事内容

Make your mark for patients

We are looking for a Quality Assurance Qualification & Validation Lead who is detail-oriented, collaborative, and proactiveto join our Quality Systems & Continuous Improvement team, based at our UCB campus in Braine-l’Alleud, Belgium.

About The Role

As a Quality Assurance (QA) Qualification & Validation Lead, you will ensure compliance with qualification and validation processes at our Braine-l’Alleud site. You will ensure that our facilities, equipment, and computerized systems meet regulatory requirements and Good Manufacturing Practices (GMP).

Who You Will Work With

You will collaborate with cross-functional teams including Qualification & Validation, production, engineering and maintenance to implement and maintain robust quality systems. You will also work closely with regulatory bodies and internal auditors.

What You Will Do

• Ensure the harmonization and oversight of the execution of qualification and validation activities (process and systems) on-manufacturing site (equipment, utilities, processes, cleaning validation and computerized systems).
• Ensure all Qualification and Validation processes and systems, strategies comply with regulatory requirements and internal quality standards.
• As Quality, approve the procedures related to the qualification and validation.
• Train and support quality teams on validation requirements and best practices.
• Ensure follow-up and communication to QA Manufacturing teams of Deviations, Planned Deviations and Change Control related to Qualification and Validation activities.
• Participate in audits (internal and external) as a Quality Qualification and validation expert.
• Ensure the continuous improvement of the related activities in collaboration with the global and local teams.
  
  

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

• Master’s degree (Engineer, Science, Pharmacy, or equivalent).
• Proven experience (5+ years) in qualification and validation within a GMP pharmaceutical environment.
• Mastery of regulatory frameworks (EU GMP, FDA, ICH, GAMP 5).
• Excellent analytical and organizational skills.
• Collaborative mindset and ability to work in cross-functional teams.
• Professional French and English are required, other languages are a plus.
  
  

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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

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.