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Head of Global Quality System
hace 2 meses
We are seeking a highly skilled and experienced professional to join our team as a Head of Global Quality System. This is an exciting opportunity to lead our global quality management system and ensure compliance with relevant government regulations.
Key Responsibilities- Manage the creation and revision of global documents, including quality policies, global SOPs, and guidelines, to support end-to-end management of quality processes.
- Establish, maintain, and develop Galderma's global Quality Management System through electronic Quality Management System (eQMS) and electronic Document Management System (eDMS), ensuring compliance with government regulations.
- Develop and maintain training plans for teams using our global Learning Management System (gLMS), ensuring qualification status is kept current.
- Establish, develop, and maintain Quality KPIs, targets, and reporting to monitor quality processes performance.
- Prepare, manage, and maintain an annual audit program, ensuring vendors oversight in areas of cGMP, GDP, ISO, Medical Devices regulations.
- Ensure regulatory surveillance of applicable government regulations, including cGMP, GDP, ISO, Medical Devices regulations.
- Background in Medical Device, pharmaceutical, or biopharmaceutical industry.
- Demonstrated knowledge and execution of Quality System Management.
- Knowledge of electronic training management systems.
- Knowledge of different regulations, including Medical Device applicable regulation, GMP, GDP regulatory requirements.
- Solid background in MS-Office suite and other IS tools.
Galderma is a leading dermatology company that values diversity and inclusion. We offer a competitive compensation package, bonus structure, and extended benefit package. We believe in ownership from day one, where everyone is empowered to grow and take on accountability.