Global Quality Assurance Leader

hace 2 meses

Barcelona, Barcelona, España GALDERMA A tiempo completo
Job Description

**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 and document management systems, ensuring compliance with government regulations.
  • Develop and maintain training plans for teams using our global learning management system, ensuring qualification status is kept current.
  • Establish, develop, and maintain quality 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 and manage an annual audit program, ensuring vendor oversight in areas of cGMP, GDP, ISO, Medical Devices regulations, and ensure attainment of annual audit plan.
  • Ensure regulatory surveillance of applicable government regulations, including cGMP, GDP, ISO, Medical Devices regulations, or any other relevant regulations and guidance.

**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 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.
  • Ownership from day one, with everyone empowered to grow and take on accountability.

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