Quality Management System

To strengthen our Quality Management & Strategy department we are looking for a talented profile to fill the position of: Quality Management System (QMS) Lead – Braine l'Alleud, Belgium.

About The Role

Reporting directly to the Head of Quality Management System, the QMS Lead provides leadership and strategy to ensure the definition, development, implementation and lifecycle management of UCB's Corporate Quality Management System.

The mission of the QMS Lead is to drive the development, implementation and maintenance of a Quality Management System framework that enables continuous improvement including innovation in design, approach and focuses adding value and maximizing agility, proactively provides emphasis on business efficiency for people, processes, and systems.

You will work with

You will work closely with senior leaders, functional QMS Leads, Quality Systems Leads, Process Owners and operational QA teams across the organization. Depending on the specific GxP scope, you will also collaborate with functions such as Global Regulatory Affairs, Patient Safety, S&TS, Clinical Development, Pharma Sciences, Biotech Sciences, Commercial Operations, Ethics & Compliance and IT. You will partner with these stakeholders to maintain and continuously improve the Quality Management System, identify and mitigate compliance risks, support regulatory inspections, drive process improvements and ensure alignment of Quality processes across the organization.

What You Will Do

Quality Management System

• Develop and execute the strategy for the Corporate Quality system aligned with the overall UCB Patient Value Strategy and objectives.
• Develops, designs and ensures that QMS remains current with respect to data integrity, data analytics and risk management (risk assessment and risk mitigation processes) whilst retaining the agility and flexibility of the processes within the QMS.
• Ensure its deployment, periodic review by senior management and lifecycle management by leveraging the Regulatory Intelligence Network process and industry benchmarking.
• Manage and develop QMS lifecycle process as Quality QMS owner, taking into consideration the impact and involvement of 'people, process and systems'.
• Lead the specific QMS Governance, in alignment with the enterprise QMS framework.
• Develop and launch QMS Maturity Program in close collaboration and agreement with senior management in Early Solutions/Development Solutions/Supply & Technology Solutions and maintain a QMS roadmap plan for the specific GxP scope QMS activities.
• Design and build the architecture for Corporate Process Owner (CPO) governance embedded in the GxP CPO overarching governance. Provide leadership and guidance to the QMS Process Owners community within the Quality organization and the relevant business organizations,
• Serve as single point of contact for all questions/process improvement initiatives/projects related to QMS.
• Assess the effort (resources, systems, organization …) and impact of any continuous improvements requests and/or additions of new processes to their QMS to prioritize the execution of the aforementioned aspects.
• Orchestrate and ensure continuous alignment with principles and ways of working of QMS across the different functional areas through engaging with key stakeholders, Functional teams and Process Owners.

Training QMS Deployment and Advisory

• Define and develop the training strategy for specific GxP scope QMS its deployment together with the Head of DevSol Learning and business leaders.
• Provide guidance and expert advice to the organization, particularly regarding the appropriate interpretation of national and international specific GxP scope regulations and guidelines.
• As QMS SME for specific GxP scope, where necessary work with relevant stakeholders to design, develop and deliver QMS-related training (& competency assessments).

Process and QMS Efficiency

• Define and implement with Business QMS Leads process measurement metrics and maturity KPI to assess the maturity of the respective specific GxP scope QMS.

Risk Management, Continuous Improvement and Change Management

• Lead improvement initiatives, identified by senior management, to improve Quality Management processes, associated systems, stakeholder engagement and their effectiveness.
• Fosters change management culture to facilitate adoption and usage of new ways of working.
• Collaborate and partner with functional units to identify and mitigate Compliance risks, resolve potential regulatory observations, elevate critical Compliance risks to upper management, and leverage internal resources and SME network to develop appropriate action plans and decisions as needed.

QMS D