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Principal Auditor Quality Assurance

Principal Auditor Quality Assurance

Pharmaceutical Research Associates, IncMexico
Hace 24 días
Descripción del trabajo

Overview

We are currently seeking a Principal Auditor Quality Assurance to join our diverse and dynamic team. As a Principal Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Responsibilities

What you will be doing

  • Leading and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines.
  • Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices.
  • Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems.
  • Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements.
  • Contributing to the continuous improvement of quality assurance programs and initiatives.

Qualifications

Your profile

  • Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
  • Minimum of 7 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with at least 3 years in a leadership role.
  • In-depth knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
  • Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
  • Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
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