Clinical FSP Quality Manager

3 semanas atrás

Buenos Aires Espírito Santo Brazil IQVIA Tempo inteiro

Join to apply for the Clinical FSP Quality Manager role at IQVIA.

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Job Overview

This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work with operations, global or regional Quality Management teams, functional teams, customers, and other stakeholders to adopt the Quality Plan, SOPs, and improve compliance with ICH, GCP, KPIs, regulatory requirements, and guidelines. This role provides advice and supports clinical staff and stakeholders on risk management, quality control, and corrective/preventive actions.

Essential Functions
  • Implement the global Quality Management Plan within the scope of the assignment, including planning and executing activities, risk assessment, and support in risk mitigation and improvement.
  • Collaborate with relevant stakeholders to maintain focus on quality in project delivery.
  • Develop and monitor the implementation of a Delivery Unit/Sponsor-specific Quality Management and Risk Management plan.
  • Advise teams on GCP compliance and support in managing non-compliance and quality issues according to SOPs.
Qualifications
  • Bachelor's Degree or equivalent.
  • Experience in Quality Management within CRO/Pharmaceutical industry.
  • Knowledge of medical terminology, SOPs, 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, including Latin America and North America.
  • Strong organizational, interpersonal, communication, judgment, influencing, and negotiation skills.
  • Proficiency in Microsoft Office.

IQVIA is a leading provider of clinical research services, healthcare insights, and medical treatments worldwide. Learn more at https://jobs.iqvia.com

Additional Information
  • Seniority level: Not Applicable
  • Employment type: Full-time
  • Job function: Quality Assurance
  • Industries: Pharmaceutical Manufacturing

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