Senior Clinical Quality Manager

il y a 2 semaines


Greater Lyon Area, France Skills Alliance Temps plein

Skills Alliance is seeking a Quality Assurance Manager to strengthen its clinical team.

Main Activities and Responsibilities:

  • Develop and track the clinical quality system to ensure effective documentation and implementation.
  • Implement and monitor risk management plans for clinical trials, ensuring compliance with established audit schedules.
  • Evaluate non-conformities, deviations, and complaints, and manage the implementation of preventive or corrective action plans.
  • Organize and oversee internal and external quality audits, including those conducted by third-party service providers.
  • Conduct quality control of clinical documentation and self-inspections, maintaining up-to-date knowledge of FDA, EU, and national regulations.
  • Lead improvements in quality systems and processes to support evolving regulations and company development initiatives.
  • Raise awareness among teams by organizing GxP-compliant quality training programs.
  • Perform other GCP-related tasks and collaborate with R&D and QA/RA departments as needed.

Requirements:

  • Bachelor's degree in a relevant field.
  • 3+ years of experience within Medical Device, Pharma, Biotechnology.
  • Extensive experience within clinical trials and quality assurance, with in-depth knowledge of GCP Quality Management Systems.
  • Fluent in verbal and written English.

Company Offers:

  • Hybrid flexibility.
  • The chance to contribute to the development of disruptive technology within a fast-growing company, working with a dynamic and supportive team.
  • Competitive salary and benefits.

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