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Global Quality System Manager

hace 2 meses

Barcelona, Barcelona, España Galderma A tiempo completo

About the Role

We are seeking a highly skilled and experienced professional to join our team as a Global Quality System Manager at Galderma. As a key member of our Operations and Commercial Quality team, you will play a critical role in establishing, maintaining, and developing our Global Quality Management System.

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 and manage an annual audit program, ensuring vendors are overseen in areas of cGMP, GDP, ISO, Medical Devices regulations.
  • Ensure regulatory surveillance of evolving 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.