ESO Quality Assurance Professional

hace 4 semanas


Barcelona, Barcelona, España Galderma A tiempo completo

About the Role

This position is responsible for ensuring Galderma products meet the company's 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 Contract Manufacturing Organizations (CMOs)/Contract Development and Manufacturing Organizations (CDMOs) and support Galderma Markets/distributors on products provided by CMOs. This role will also play a key part in working with Active Pharmaceutical Ingredient (API) suppliers.

Key Responsibilities

  • Promote improvement programs and alignments in all related CMO/CDMO.
  • Be actively involved in the resolution of critical/major quality issues (leading to supply issues) and to discrepancies found through audits, inspections, or complaints and their related investigations.
  • This position will accompany CMO/CDMO to favor continuous improvement program 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 the applicable regulations for drugs, cosmetics, medical devices or a similar industry.
  • Capacity to negotiate and manage external partners.
  • Possess ability to work in 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.

What We Offer

  • You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  • You will receive a competitive compensation package with bonus structure and extended benefit package.
  • You will be able to work in a hybrid work culture.
  • You will participate in feedback Loops, during which a personalized career path will be established.
  • You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.


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