Quality Assurance Associate Director, EPM

Implement, manage and lead local QA teams, both consultants and employees
Lead / manage regional and local Health Authority interactions, queries and inspections
Develop, implement and maintain Medison Quality Management Systems (QMS) ensuring that GxP and all other compliance obligations are successfully met, both regionally and locally
Ensure that Corporate Procedures and Standards are properly deployed into the local QMS and managed accordingly
Ensure GxP training programs are implemented and maintained
Oversee and implement a robust Vendor Management and oversight program, suitable for an organization which operates an outsourced model
Prepare and conduct self-inspections and audits
Manage any deviations, corrective and preventive actions and change controls that may arise internally or via customer and vendor channels
Escalate any suspected deficiencies to key Management within the EPM Management structure
Implement an appropriate management review system, ensuring that any trends are escalated and managed appropriately
Gather, maintain and communicate Key Performance Indicators (KPI`s) for quality assurance in accordance with corporate QA guidelines and local needs
Ensure third party Vendors or Business Partners are properly qualified, monitored and processes are compliant (e.g. storage, distribution, late-stage customization, etc.)
Support in negotiation of relevant agreements including but not limited to Quality Technical Agreements (QTA) for Vendors and Suppliers as requested
Coordinate local recalls in collaboration with partners and Medison management
Ensure that Global QA and Local Business leadership are kept informed of all relevant activities
Work in partnership with other departments / functions to ensure proper support to product launches and achievement of commercial timelines
Manage multiple Supply models across different territories and products across the EPM region, ensuring compliance with key legislation is maintained during supply
Lead the Quality Assurance function, ensuring that key processes are in place to compliantly supply both EU and non-EU markets in the EPM region
Ensure that a proactive approach is taken to license management, overseeing all activities relating to both acquiring and maintaining key regional and local licenses in both Switzerland and the EPM region
Manage regional and local resource planning for the QA organization, ensuring that key talent is recruited regionally and locally as required
Drive compliance within the EPM region, ensuring adherence to regional and local legislation