Global Quality System Manager
hace 1 mes
Job Summary
The Head of Global Quality System will be responsible for establishing, maintaining, and developing Galderma's Global Quality Management System. This role will ensure compliance with relevant government regulations, including cGMP, GDP, ISO, and Medical Devices regulations.
Key Responsibilities
- Manage the creation and revision of Global Documents, including Quality Policies, Global SOPs, and Guidelines.
- Establish and maintain the electronic Quality Management System (eQMS) and the electronic Document Management System (eDMS) while ensuring compliance with government regulations.
- Develop and maintain training plans for teams using the global Learning Management System (gLMS).
- Establish and maintain Quality KPIs, targets, and reporting to monitor quality processes performance.
- Prepare and manage an annual audit program to ensure vendors' oversight in areas of cGMP, GDP, ISO, and Medical Devices regulations.
- Ensure regulatory surveillance of the evolution of applicable government regulations.
Requirements
- 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 and GMP regulatory requirements.
- Solid background in MS-Office suite and other IS tools.
What We Offer
- A competitive compensation package with bonus structure and extended benefit package.
- A hybrid work culture.
- Feedback Loops and personalized career path.
- Ownership and accountability from day one.
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