Quality Management System Manager

Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions. Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position title: Quality Management System Manager Reports to: Corporate Quality Director. Position Summary: The Quality System Management Manager is responsible for evaluating quality system processes, developing action plans, and coordinating the strategic implementation of quality system initiatives and corrective actions within the plasma donor center. In this role, the manager provides direct supervision and leadership to the Quality Assurance Specialist and the Document and Quality Support Specialist, ensuring the effective execution of quality management activities and continuous process improvement. The Quality System Management Manager is accountable for ensuring the effective management of the Quality System and for monitoring, tracking, and recording all activities that directly or indirectly impact product quality, donor suitability, donor safety, and GxP processes across the Plasma Supply Chain. The role also includes conducting periodic assessments of the Quality System through the analysis of established key performance indicators (KPIs), identifying opportunities for improvement, and supporting compliance with applicable quality and regulatory requirements. Key responsibilities: Directs and monitors processes and ensure proper implementation of Quality systems (Documentation, Deviation and CAPA management) in Grifols Canadian Plasma supply chain areas. Ensure compliance with all regulations as mandated by the applicable regulatory authorities and company policies in timely manner and without overdue. Ensures the implementation of a robust Risk Management system among Plasma Supply Chain areas. Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance. Collaborates with the Center Manager to ensure the donor center operates in a manner which assures product quality, donor suitability and donor safety are maintained. Establishes KPI related to Quality systems and evaluate through the different Quality system KPI’s among Plasma Supply Chain areas. Responsible for oversight of all aspects of internal and external audits including audit preparation, execution, response, development and implementation of corrective/preventative (CAPA) actions, development and assessment of CAPA effectiveness. Assesses, promotes, and improves the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct. Documents, investigates, and performs root-cause analysis for deviations, specifically in how they relate to the safety of the donor and the quality of the product. Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness. O…

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