Head of Global Quality Management
hace 1 mes
Join our team at Empresa Reconocida as we seek a highly skilled and experienced professional to lead our Global Quality System. As a key member of our Operations and Commercial Quality team, 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 quality processes.
- Establish, maintain, and develop our global Quality Management System through electronic Quality Management System (eQMS) and electronic Document Management System (eDMS), ensuring compliance with government regulations.
- Ensure the qualification status of these tools is kept current.
- Develop and maintain training plans for teams using our global Learning Management System (gLMS), ensuring the qualification status of this tool is kept current.
- Establish, develop, and maintain Quality KPIs, targets, and reporting to monitor quality processes performance.
- Develop, maintain, and improve templates for Quality KPI Dashboards, Quality Management Reviews, and participate in Global Quality Reviews.
- Prepare, manage, and maintain an annual audit program, ensuring vendors oversight in areas of 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, and GDP 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, with a personalized career path established.
- A growing company that believes in ownership from day one, where everyone is empowered to grow and take on accountability.
Process Steps:
- Send your CV in English.
- If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
- The next step is a virtual conversation with the hiring manager.
- The final step is a panel conversation with the extended team.
Join our team at Empresa Reconocida and take on this exciting opportunity to lead our Global Quality System
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