Head of QMS Transformation

UCB

Eigenbrakel

Hybrid

EUR 140,000 - 170,000

Full time

10 hours ago
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Job summary

UCB is seeking a Head of QMS Transformation to lead the design, implementation and adoption of a future enterprise QMS. You will steer transformation across GxP domains, drive process harmonization, and ensure inspection readiness while enabling digital platforms and data-driven improvements.

The role requires strong leadership, global collaboration and change management to align strategy with practical, scalable adoption across the organization.

Qualifications

  • Bachelor's or master's degree in a relevant scientific discipline is required.
  • Fluent English in speech and writing; other languages are a plus.
  • Extensive knowledge of Quality Management Systems in regulated biopharma, including GxP, QMS operating models and inspections.

Responsibilities

  • Provide strategic direction for the future enterprise QMS and operating model.
  • Lead multi-year transformation workstreams with governance, planning and delivery discipline.
  • Translate quality strategy into actionable roadmaps, priorities and measurable outcomes.
  • Manage risks, dependencies and decision points across the transformation program.
  • Drive digital QMS deployment and value realization across platforms and processes.

Skills

Strategic leadership
QMS knowledge
Change management
GxP compliance
Stakeholder management
Digital transformation
QMS platforms
Process improvement

Education

Bachelor's/Master's in life sciences
Advanced degree in quality/regulatory

Tools

eQMS platforms
Workflow tools
Quality data tools

Job description

To strengthen our Quality Systems & Governance we are looking for a talented profile to fill the position of: Head of QMS Transformation – Braine l’Alleud, Belgium.

About The Role

Reporting to the Head of Quality Management & Strategy, the Head of QMS Transformation is responsible for providing strategic direction and delivery oversight for the design, implementation, deployment and adoption of the future enterprise Quality Management System.

The mission of the Head of QMS Transformation is to shape, lead and ensure the successful embedding of a simplified, harmonized, effective and inspection-ready enterprise QMS that supports compliant, risk-based and sustainable operations across GxP domains and enables simplification, digital enablement, user adoption, continuous improvement and enterprise consistency.

You will work with

The role operates in a multi-year transformation context and acts as a transformation leader across QMS domains, providing direction, integration and governance across strategic workstreams, future-state operating model design, process harmonization, digital platform implementation, quality data and performance initiatives, document and training transformation, and organizational change management.

The role requires the ability to influence leaders, orchestrate cross-functional decisions, coach and guide transformation contributors, and ensure that strategic design choices are translated into practical, scalable and sustainable business adoption.

What You Will Do

Strategic QMS Transformation Leadership

  • Provide leadership for the design and implementation of the future enterprise QMS operating model.
  • Lead complex, high-impact transformation workstreams within the QMS Transformation Program, ensuring clear direction, integrated planning, stakeholder alignment and delivery discipline.
  • Translate enterprise quality strategy and transformation objectives into actionable roadmaps, priorities, governance mechanisms and measurable outcomes.
  • Anticipate, manage and elevate strategic risks, dependencies, trade-offs and decision points requiring leadership attention.

Enterprise Process and QMS Improvement Leadership

  • Lead the redesign, harmonization and simplification of enterprise quality processes, ensuring a balanced focus on compliance, efficiency, user experience, scalability and inspection readiness.
  • Guide process owners and subject matter experts in defining future-state processes, governance models, escalation pathways and accountability frameworks.
  • Set expectations for process maturity, performance and effectiveness assessments and ensure insights are translated into strategic improvement actions.

Digital and Technology Transformation Leadership

  • Provide business leadership for the deployment and evolution of digital QMS solutions, including eQMS, workflow tools, knowledge management solutions and process management technologies.
  • Partner with business, IT, digital teams and external partners to ensure business requirements, user needs and implementation priorities are aligned with strategic QMS objectives.
  • Drive value realization from digital investments by ensuring that tools, data, workflows and ways of working deliver measurable business and quality benefits.

Organizational Change Leadership and Adoption

  • Act as a change leader throughout the QMS transformation journey, shaping the adoption strategy and ensuring transformation readiness across impacted stakeholder groups.
  • Define and oversee stakeholder engagement, communication, training and adoption plans for major transformation deliverables.
  • Influence key stakeholders and drive cross-functional alignment, decision‑making and buy‑in in a complex global matrix organization.

QMS Documentation, Standards and Knowledge Framework Leadership

  • Lead or provide guidance for the design and implementation of the future-state QMS documentation hierarchy, standards framework, metadata, taxonomy and traceability principles.
  • Ensure strategic alignment between QMS architecture, process design, controlled documents, training requirements, records and enabling systems.
  • Set quality expectations for new or revised QMS content to ensure it is clear, fit‑for‑purpose, sustainable, inspection-ready and aligned with enterprise standards.

Quality Data, Performance and Continuous Improvement Leadership

  • Lead initiatives related to QMS metrics, performance monitoring, maturity assessment, dashboards and data‑driven decision‑making.
  • Integrate insights from audits, inspections, deviations, CAPAs, management reviews, regulatory intelligence, benchmarking and user feedback into the QMS transformation roadmap.
  • Set direction for continuous improvement priorities and promote a culture of simplification, quality excellence and sustainable compliance.

Inspection Readiness and Compliance Leadership

  • Ensure transformation design choices and deliverables remain aligned with applicable GxP regulatory expectations, quality risk management principles and inspection readiness needs.
  • Provide oversight for audit and inspection readiness activities related to transformed QMS processes, systems, governance and documentation.
  • Anticipate and mitigate compliance risks arising during design, deployment and adoption of new QMS capabilities.
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 communication (oral and written); any additional languages are a plus.
  • Extensive knowledge of Quality Management Systems in the regulated biopharmaceutical industry, including GxP expectations, QMS operating models, process management, controlled documents, quality risk management, inspections and continuous improvement.
  • Proven experience leading large-scale quality, compliance, operational excellence, digital or enterprise business transformation initiatives in a complex global environment.
  • Ability to shape strategy, define direction and make sound recommendations in areas of ambiguity, complexity and organizational sensitivity.
  • Advanced systems-thinking capability, with the ability to connect processes, technology, governance, data, documentation, training, culture and organizational design within an enterprise quality system.
  • Strong stakeholder management, facilitation, communication, negotiation and influencing skills, including the ability to engage leaders and drive alignment across functions without direct authority.
  • Demonstrated change leadership capability, including adoption strategy, communication planning, capability building, resistance management and sustainment of new ways of working.
  • Ability to lead through complexity, challenge constructively, simplify enterprise problems and enable pragmatic, risk-based decision‑making.
  • Strong program and workstream leadership skills, including integrated planning, prioritization, dependency management, risk management, governance and delivery oversight.
  • Good understanding of digital QMS platforms, workflow tools, data integrity principles, quality metrics, reporting concepts and value realization from digital transformation.
  • Excellent executive-level communication skills, including the ability to prepare leadership messages, influence decisions and present complex topics in a clear and compelling manner.
  • Ability to coach, guide and develop transformation contributors, subject matter experts and business representatives involved in QMS transformation activities.
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.

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