Quality Management System (QMS) Lead

Make your mark for patients

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, escalate critical Compliance risks to upper management, and leverage internal resources and SME network to develop appropriate action plans and decisions as needed.

QMS Documentation Framework

- Maintain strategic oversight of specific GxP scope QMS E2E Documentation Architecture (linking between processes/documents) and ensure the Enterprise standards are applied.
- Orchestrate and manage specific GxP scope QMS related Gap Analysis (GA) phase with functional QMS Leads for the impact to functional or local level documents (with a focus on processes, systems and people).

Audits and Inspections

- Provide inspection support to health authority inspections and customers audits at UCB sites and inspections of UCB Quality Management Systems as needed and be point of contact for Process Owners.
- Partner and network with QA operational teams to prepare sites for pre-approval and/or routine regulatory inspections.

- Maintain oversight of inspection and audit related CAPAs for QMS Processes.

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.
- Deep, sustained and current knowledge in and experience with Quality Systems in the regulated biopharmaceutical industry in Quality Management System and related operations (ie processes, systems, personnel).
- Maintains a comprehensive working knowledge of data integrity and risk management (risk assessment and risk mitigation).
- A good and thorough understanding of current regulatory requirements and expectations (e.g. US, Europe, Japan, China) and an ability to interpret current regulations and requirements in the product development and clinical trials context is essential
- Must have excellent presentation skills and the ability to present content in an influential / compelling manner in front of senior management · Works entirely independently with minimal supervision yet is a team player with and in a proactive approach.
- Ability to present complex projects and issues to senior management in a clear, succinct, coherent manner.
- Negotiation skills and a proven ability to influence senior leaders and others within a global matrix organization
- Must have the ability to adapt the delivery of message (ie strategy, process, training) to any audience, with an engaging, collaborative and influential manner.
- Must be knowledgeable of risk analysis techniques (FMEA, …), must be able to identify and evaluate risks and propose mitigation plans within complex situations
- Proven analytical and investigation skills to understand global, complex Compliance and Regulatory issues
- Excellent planning and organizational skills with the ability to prioritize according to company priorities, Compliance and Patient Safety risk

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 [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.