GMP Process and Operations Compliance Lead

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

Extensive 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

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 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.

 

Requisition ID: 93020

Recruiter: Aurélie Cuisset

Hiring Manager: Christine Goffaux

Talent Partner: Caroline Lonchay

Job Level: MM II

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