Director, Quality And Regulatory

hace 1 mes


Barcelona, España Thermo Fisher Scientific A tiempo completo

.Thermo Fisher Scientific - Barcelona, Spain Details Negotiable Full-Time 1 position When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.Position Summary:The Director, Quality and Regulatory will oversee the High-Performance Chromatography Solutions (HPCS) and Software Business Unit quality system and quality assurance strategies. Reporting to the Vice President of Chromatography & Mass Spectrometry Division (CMD) QARA, this position will be responsible for ensuring the highest level of quality and compliance in our operations, products, and services. Your expertise and leadership will be instrumental in driving continuous improvement, implementing quality management systems, and ensuring regulatory compliance in a rapidly evolving industry. This role will provide leadership by ensuring strategic quality planning, regulation monitoring, and QMS integration/improvement activities are effectively established and maintained according to business needs.Key Responsibilities:Build and drive a Quality vision and strategic objectives that aligns with our High-Performance Chromatography Solutions BU.Lead and inspire a strong global quality team by hiring and developing strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.Drive operational excellence by effectively using continuous improvement skills and tools to prioritize and drive projects and improvements/standardization across the network to improve Product Quality, reduce costs of poor quality, and align with strategic objectives.Establish network wide QA priorities and key objectives to improve the compliance to regulations and the global Quality Management System.Ensure global QMS training is effective and operate within the required regulatory guidelines.Uphold awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulationAssess product regulations and standards and the impact to meet global requirementCollaborate with corporate & divisional partners regarding quality issues, audits, and special projectsInfluence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.Ensure effective management of the global Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, NPDI.Drive the continuous improvement of Quality Management Systems, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, and NPDI process support



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