ESO Quality Specialist

hace 4 semanas


Barcelona, Barcelona, España Galderma A tiempo completo

Job Summary

This position is responsible for ensuring Galderma products meet quality standards and comply with relevant government regulations. The ESO Quality Specialist will rely on regulatory, industry, and technical expertise to select, monitor, guide, and promote quality at CMOs/CDMOs and support Galderma Markets/distributors on products provided by CMOs.

Key Responsibilities

  • Promote improvement programs and alignments in all related CMO/CDMO.
  • Be actively involved in the resolution of critical/major quality issues and discrepancies found through audits, inspections, or complaints and their related investigations.
  • Accompany CMO/CDMO to favor continuous improvement programs and preventive actions over corrective actions.
  • Provide expert interpretation and application of regulatory guidelines to ensure that CMO/CDMO/API Suppliers adhere to regulatory requirements and are consistent with industry standards.
  • Notify management of significant quality or regulatory issues that may impact product quality or regulatory compliance.

Requirements

  • Solid experience in Quality Assurance role.
  • Strong knowledge of applicable regulations for drugs, cosmetics, medical devices, or a similar industry.
  • Capacity to negotiate and manage external partners.
  • Possess ability to work in a matrix organization (affiliates, global, CMO/CDMO).
  • Communicate clearly and professionally in both writing and verbally in English and French.
  • Flexibility and agility in problem-solving, providing direction to meet business objectives are expected.


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