What you will doAs a Sr. Manager QMS you will build Santen EMEA Regional Quality Governance Structure to ensure that EMEA Quality Management System (QMS) processes are working properly, and continuous improvement is achieved. Make sure that adequate KPIs are set to monitor Quality Systems health.Furthermore, you will also be responsible for;Leading EMEA Quality Audit Management. Roll out of the consolidated supplier risk assessment and audit plan (CMO, API,GDP,ISO).  Deploy new Risk Management across the EMEA QA Functions and drive risk mitigations activities.Establish EMEA Learning Management System Training Matrix covering GxP/ISO.Play key role in quality management system related activities to ensure continuous compliance of Santen EMEA to applicable EU pharma, distribution and medical devices regulations (EU GDP, MDD/MDR, ISO13485)In alignment with Santen vision and with EMEA Quality strategy, objectives and directions, and in compliance with any external or internal regulatory requirements:To lead and manage activities and projects related to the development, standardization, implementation, monitoring and continuous improvement of the EMEA Quality management system ensuring: - Robust best-in-class, standardized policies, procedures, guidelines and models. - Effective and efficient roll-out and monitoring across all EMEA entities.To manage consolidated EMEA Quality Audit Plan to achieve:Health Authority Inspection Readiness in EMEAQualified EMEA Auditor PoolTo deploy new Risk Management Process across EMEA QA Functions and optimize the risk register by consolidation.To design GxP Training Matrix for the quality systems under the responsibility.To support quality operational tasks and cross-functional projects related EMEA Quality Management System (QMS) in connection with EMEA Director QMS and IT quality.To be the back up of SAP Quality Module Key User for EMEA
