Ensure Global Quality Standards

Há 7 dias

Buenos Aires Espírito Santo Brazil beBeeQuality Tempo inteiro
Quality Assurance Manager

This role involves implementing a quality management plan across various delivery units, sponsors, business lines, and tasks as defined by the line manager. The incumbent will be responsible for planning and executing activities, conducting risk assessments, and supporting risk mitigation and improvement.

Key Responsibilities:
  • Develop and implement a Quality Management Plan to ensure compliance with Good Clinical Practice (GCP) and adherence to Standard Operating Procedures (SOPs).
  • Collaborate with stakeholders to maintain focus on quality in project delivery.
  • Design and execute a Delivery Unit/Sponsor-specific Quality Management and Risk Management plan.
  • Provide guidance to teams on GCP compliance and support in managing non-compliance and quality issues.
Requirements:
  • Bachelor's Degree or equivalent qualification.
  • Experience in quality management within Contract Research Organizations (CROs)/pharmaceutical industry.
  • Knowledge of medical terminology, SOPs, International Conference on Harmonisation (ICH), GCP, regulatory requirements, and quality processes.
  • Understanding of national and international drug development regulations.
  • Knowledge of CRO or pharmaceutical operations and IQVIA standards.
  • Fluent in English.
  • Ability to travel up to 80% within the region/country.
  • Strong organizational, interpersonal, communication, judgment, influencing, and negotiation skills.
  • Proficiency in Microsoft Office.

Company Overview: A leading provider of clinical research services, healthcare insights, and medical treatments worldwide.

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