QA Manager - QC Process Support

Make your mark for patients

To strengthen our Global QA for QA Operations department we are looking for a talented profile to fill the position of: QA Manager – QC Process Support – Braine l’Alleud, Belgium.

About the role

The QA Manager – QC process support provides quality expertise and ensures appropriate global oversight of Patient Supply Quality Control processes, with a primary focus on the execution of QC processes and related projects, including specifications, stability studies (protocols and reports), analytical reference standards, critical materials and standards, laboratory third parties, compendial changes and raw‑material vendor certification.

You will work with

The QA Manager – QC process support works closely with Patient Supply Quality Control teams, relevant supporting functions, and external laboratory partners and Contract Laboratory Organizations (CLOs). The role collaborates cross‑functionally to ensure compliant execution of global QC activities, effective management of QC processes such as management of critical materials and stability studies, and smooth coordination between QC, supporting services, and external partners.

What you will do

Back-up Function

• The position can act as back-up for his direct colleagues or for his manager according to the manager’s instructions and after appropriate training

General QA Role

• Using a Risk Based Approach, ensure that PSQC Processes & Operations are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Policies & Procedures
• Drive quality leadership and provide technical expertise on compliance strategy.
• Communicate processes requirements effectively across functional areas.
• Promoting culture of quality, operational excellence and “SOSD” (See it, Own it, Solve it, Do it) attitude within Patient Supply Quality Control.
• Deliver general cGMP training and effective coaching on QMS to relevant stakeholders.
• Communicate compliance status and issues to appropriate organizational levels.
• Support regulatory inspections/audits, providing dynamic assistance to SME’s.

Patient Supply Quality Control Process

1. • Participate in the improvement of the PSQC processes
   • Ensure adequate coaching and training of relevant stakeholders on the PSQC processes
   • Oversee critical global activities to ensure analytical operations are conducted in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
   • Ensure subcontractors supporting QC routine operations maintain adequate cGMP standards
   • Implement and maintain adequate Quality & Compliance indicators and communicate results to appropriate levels of the organization

Continuous Improvement

1. • Identify, coordinate and support opportunities for improvement and operational excellence projects in response to business needs, technical changes, risks, audit observations and regulatory requirements.
   • Lead or co-lead internal quality spot checks/audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
   • Conduct or support Quality Reviews exercises (e.g. Management/Product Reviews, etc)
   • Identify, coordinate and support Continuous Improvement projects (LEAN, 6-Sigma, Green belt and others) with QC management to enhance quality KPI’s and product/process quality.

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 & French communication (oral and written)
• Strong knowledge and proven experience in Quality Control and applicable regulations
• Proven understanding of QC processes: stability studies, material management, specification management.
• Experience with Quality Management System and Internal/External Auditing
• Ability to balance multiple priorities, provide leadership and prioritisation, and work with minimal supervision
• Fact based decision maker with accountability and delivering attitude
• Excellent team player attitude with excellent interpersonal relationship and communication skills
• Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
• Able to perform effectively in high‑pressure situations

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.