MES Quality Lead

Hobson Prior are looking for a MES Quality Lead to join a brilliant pharmaceutical organisation on a contract basis, located in Belgium. Our Client is focused on improving access and affordability to create healthier communities.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this position you will be responsible for Lead execution and deployment of MES processes to ensure quality and compliance.
• Provide support for the deployment of MES systems.
• Keep project schedules and deliverables on track.
• Develop MES standards and harmonize processes.
• Promote stakeholder engagement.
• Ensure that management is aware of project issues and that areas of interdependence are addressed in a proper manner.
• Oversee the access of users to critical roles in a timely and efficient manner.
• Organize and lead MES Quality Management Reviews, CAPAs, and Change Control Boards.
• Connecting QA users across different sites to improve GXP processes within the MES system.
• Approve global documents associated with MES.
• Manage any global investigation, CAPA, or Change Control related to MES systems.
• Maintain audit readiness of MES systems.
• Provide support for exercises conducted on the MES systems as part of the Periodic Review process.
• Organize and facilitate System Forums/Community of Practice meetings on a regular basis.
• Lead the decision-making process for site quality processes in collaboration with the quality teams on site.

Key Skills

• Ability to influence/negotiate at all organizational levels.
• Think independently.
• A pragmatic approach.

Requirements:

• Bachelor's degree or higher in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering). Master's degree preferred.
• A minimum of 10+ years of combined experience in manufacturing, quality assurance, quality control, validation, or engineering for vaccines or pharmaceuticals is generally required.
• Experience with the business environment inside a quality organization across various roles (e.g., quality operations, quality control, quality systems) is preferred.
• It is essential that you know the applicable regulations.
• Experience in a GMP (Pharmaceuticals, Medical Devices) regulated environment is preferred.
• Knowledge of ISO requirements is essential.
• An understanding of quality systems, such as Investigation/CAPA, Document Management, the Management Review process, etc., is required.
• Ability to build respectful and productive partnerships with peers and strong leadership/facilitation skills.
• An understanding of how to navigate and deal effectively within a matrix organization, managing complexity, engaging and collaborating across boundaries, and influencing without line authority.
• Communication skills (verbal, written, presentation) as well as self-awareness and adaptability are required.
• An experienced results-oriented professional with a proven success.
• An expert in conflict resolution and problem-solving.
• Dedicated to achieving results and collaborating with others.
• Self-sufficient and able to work collaboratively with others when needed.
• Experience and skills in Project Management.
• An understanding of project methodologies and the importance of process excellence.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.