Head of Global Quality Management
hace 5 días
**About the Role**
We are seeking a highly skilled and experienced professional to lead our Global Quality Management System. As the Head of Global Quality Management, you will be responsible for establishing, maintaining, and developing our global quality management system to 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 our global quality management system through electronic quality management systems (eQMS) and electronic document management systems (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 key performance indicators (KPIs), targets, and reporting to monitor quality process performance.
- Develop and maintain templates for quality KPI dashboards, quality management reviews, and participate in global quality reviews.
- Prepare, manage, and maintain an annual audit program, ensuring vendor oversight in areas of cGMP, GDP, ISO, Medical Devices regulations.
- Ensure regulatory surveillance of applicable government regulations, including cGMP, GDP, ISO, Medical Devices 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, GMP, GDP, and ISO.
- 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 for personalized career path development.
- Ownership and accountability from day one.
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