GMP Process and Operations Compliance Lead

UCB; Eigenbrakel; Hybride; EUR 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

UCB is seeking a GMP Process and Operations Compliance Lead to join the Clinical Manufacturing team in Belgium. You will drive high-quality manufacturing operations while ensuring regulatory compliance across Chemical, Biological and GT pilot plants, working with QA and sustainability stakeholders.

You will lead a team, oversee deviation investigations, risk management, and continuous improvement, and collaborate with pilot plants, quality partners, and leadership to strengthen the quality

Qualifications

• Bachelor’s or Master’s degree in a scientific discipline required.
• Minimum 10 years in biopharmaceutical manufacturing or equivalent.
• Strong knowledge of regulations for low bioburden and sterile manufacturing.
• Experience with Deviations/Investigations, root cause analysis, and change management.

Responsabilités

• Lead quality and regulatory compliance across clinical manufacturing processes across pilot plants.
• Coach teams to embed a robust quality mindset and oversee deviation management and change controls.
• Coordinate audits, inspections, and compliance visits.

Connaissances

Leadership

Quality governance

Root cause analysis

Agile environment

French & English

Formation

Bachelor’s or Master’s in science

Description du poste

Make your mark for patients

We are looking for a

l’Alleud, Belgium.

About The Role

You will play a key role in ensuring high standards of quality and regulatory compliance across clinical manufacturing operations. You will support safe, compliant manufacturing processes while driving continuous improvement Working in a complex, regulated environment, you will help teams deliver high ‑ quality products that support patient needs worldwide.

Make your mark for patients

We are looking for a GMP Process and Operations Compliance Lead who is collaborative, quality ‑ driven, and proactive to join our Clinical Manufacturing team ( Pharma and Biologicals, mAb and Gene Therapy), based in Braine ‑ l’Alleud, Belgium.

About The Role

You will play a key role in ensuring high standards of quality and regulatory compliance across clinical manufacturing operations. You will support safe, compliant manufacturing processes while driving continuous improvement Working in a complex, regulated environment, you will help teams deliver high ‑ quality products that support patient needs worldwide.

Who You’ll Work With

You will be working in a multidisciplinary team that brings together manufacturing, engineering, supply, and quality professionals. You will collaborate closely with pilot plant teams, quality partners, and leadership to maintain compliance, share best practices, manage risks and foster a strong quality culture.

What You’ll Do

• Lead quality and regulatory compliance across clinical manufacturing processes and operations, working transversally across Chemical, Biological and GT pilot plants
• Act as a leader and coach, supporting teams in strengthening a consistent quality mindset and embedding best practices in daily operations.Overseedeviation management, ensuring robust timely investigation processes, suitable actions plans, and appropriate change controls.
• Lead the resolution of complex quality issues
• Proactively identify, assess, and manage quality risks related to manufacturing process and operations
• Define, Monitor and analyze quality performance indicators, driving continuous improvement initiatives across clinical manufacturing activities.
• Ensure effective quality Governance, including the organization and leadership of Quality Councils in close collaboration with QA and stakeholders.
• Coordinate audits, inspections, and compliance visits across pilot plant facilities
• Lead and develop a team of compliance professionals, fostering engagement, accountability, and professional growth.
• Act as a key contributor to the evolution of UCB standards, reviewing them constructively and fostering transversal alignment to strengthen compliance.

Interested?

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

• Bachelor’s or Master’s degree in a scientific discipline
• At least 10 years of experience in biopharmaceutical manufacturing
• Strong knowledge of regulations related to low bioburden and sterile manufacturing activities
• Strong knowledge of quality systems and production systems including documentation, and training management
• Strong Experience with Deviations/Investigations, root cause analysis, and change management
• Experience in managing Quality Governance and KPIs
• Decision maker, Problem solving skills in a very agile environment
• Proven ability to lead, coach, and develop a team
• Strong communication skills in French and English, written and spoken

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.

Hybrid Work

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.

Equal Opportunity Statement

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Reasonable Accommodation

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [e-mail]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.