To strengthen our Global QA Compliance Operations department, part of Internal Manufacturing Quality (IMQ) we are looking for a talented profile to fill the position of: Head of QMS, Documentation and Training– Braine l’Alleud, Belgium.
About The Role
The Head of QMS, Documentation and Training, is a senior position within the Quality Compliance Operations team, reporting directly to the Head of QA Compliance Operations.
The position focus will be to ensure strategic oversight, harmonization, and continuous improvement across all internal manufacturing sites and strong alignment with External Manufacturing organization, of Quality Management Systems (QMS) that include documentation & training, Regulatory Intelligence, Deviation, Investigation, CAPA, Change Control, Archiving, Metadata & workflow definitions etc.
This strategic role ensures that the Quality Management Systems (QMS) across individual operational sites in UCB are implemented in an aligned manner and maintained continuously to meet regulatory requirements and internal corporate standards.
While executing these Global activities the role needs to foster a culture of continuous improvement, process optimalization, driving operational excellence and implement process & value driven Digitalization, and collaborate with key stakeholders globally across UCB Units to uphold and enhance the organization’s quality standards.
You will work with
In this role, you will work closely with various stakeholders across UCB's internal and external manufacturing organizations. You will collaborate with the Internal Manufacturing Quality Assurance Leadership team, the QA Compliance Operations Leadership team ensuring alignment and harmonization of quality management systems (QMS) across all operational sites. Additionally, you will engage with the External Manufacturing organization to align processes. You will also interact with key stakeholders globally across UCB Units to foster a culture of continuous improvement, process optimization and wherever there is a process and value driven digitalization opportunity while supporting the organization’s quality standards.
What You Will Do
Lead a global quality team that supports operational and strategic activities, provide development opportunities while being value driven.
Lead Gemba sessions across UCB Sites/ Departments to understand existing quality processes part of the role and systems, identify inefficiencies and identify Value Digitalization when needed.
Oversee the implementation and ongoing improvement of Quality Management Systems (QMS) to ensure compliance with regulatory requirements and internal governances and policies.
Drive the harmonization and standardization of quality practices across internal and manufacturing sites, fostering consistency and compliance globally.
Support the Head Performance, Operational Excellence in driving Continuous Improvement initiatives aiming on enhancing efficiency, reducing risks, and maintaining high standards of compliance.
Support the Head Audit and Inspection Readiness in managing risks and participating in audits and inspections when required.
Lead regulatory intelligence activities, including compliance projects (e.g. china market compliance project).
Promote a culture of innovation and continuous learning within the team and across the organization.
Oversee and innovate training programs within IMQ to ensure staff are well‑versed in regulatory requirements, quality standards, and operational processes.
Oversee the training matrix, onboarding and development of people within the team.
Serve as the transversal IMQ Single Point Of Contact (SPOC) for Quality Compliance topics below:
CAPA management
Deviation management
Change Control management
QMS Documentation management
Training management
Archiving management
Staff Qualification and training management (including GMP training)
Regulatory Intelligence management
Metadata and Workflow definitions
Partner with key stakeholders to ensure alignment on quality processes and build regular networking communication (e.g. monthly meeting, monthly gemba…)
Integrate any new IM UCB site into QMS through strategy definition while implementing onboarding plans, including training programs, documentation harmonization, …
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
Minimum of 10 years in Quality Assurance or/and Quality Systems Operations or/and Quality Compliance within a regulated pharmaceutical environment or equivalent
Fluent English communication (oral and written); any additional languages are a plus
Deep understanding of cGMP principles and global regulatory environments
Proven track record in quality systems implementation
Proven track record in leading a team of people across the world
Experience in participating in audits and inspections (FDA)
Experience in Value driven Digitalization is a plus
PMO, green belt, lean & six sigma is a plus
Excellent organizational and analytical abilities to manage projects
Expertise with Quality Management System
Expertise with quality processes: documentation, training, CAPA, deviations, investigation, change control, archiving, risk analysis & mitigation, regulatory intelligence
Exceptional communication and interpersonal skills for effective stakeholder engagement
Strategic thinking with the ability to foster a culture of Quality, Continuous Improvement and Innovation
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 explicitly 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 federal, state, or local law. UCB invites you to voluntarily self‑identify during the application process. Provision of self‑identification information is entirely voluntary and a decision to provide or not provide such information will not have any effect on your application for employment, your employment with UCB, or otherwise subject you to any adverse treatment. Any information you provide will be considered confidential and will be kept separate from your application and/or personnel file and will only be used in accordance with applicable laws, orders, and regulations.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US-Reasonable_Accommodation@ucb.com for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
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