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Director of External Service Provider Quality Assurance

hace 2 meses

Madrid, Madrid, España Interstate Ac Service A tiempo completo

**Job Summary**

As our Associate Director External Service Provider QA, you will play a pivotal role in managing external service providers across GxP areas in Global R&D Quality, ensuring that our partners meet the highest standards of excellence.

**Key Responsibilities:**

  • Provide QA expertise and guidance to ensure compliance with regulatory requirements, including implementation of quality risk-based and GxP-relevant processes.
  • Review and approval of External Service Providers (ESP) qualifications, ensuring adequate Quality Assurance Agreements (QAA) / quality terms are in place.
  • Lead and manage quality oversight, collaborating with business partners and other quality groups to ensure health authority and regulatory requirements are fully met.
  • Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.
  • Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP.
  • Ensure quality and compliance gaps are addressed and executed for sustainability, implementing strategic process improvement, including review of procedural updates, quality issues, effectiveness checks, etc.
  • Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management, and follow-up.
  • Support Audit team for audit planning and timely completion of audit CAPA, as well as clinical trial team for oversight/management of external service providers and IT systems supporting research and development activities.

**Requirements:**

  • Proven experience in quality assurance and regulatory compliance.
  • Strong leadership and management skills.
  • Excellent communication and interpersonal skills.
  • Ability to work in a fast-paced environment and prioritize multiple tasks.