Quality Management Specialist

6 dagen geleden

Utrecht, Utrecht, Nederland HKU Voltijd

Job Summary

The Clinical Trials Centre at HKU is seeking a highly skilled Quality Management Specialist to join its Quality Management Team (QMAT). As a key member of the team, you will be responsible for ensuring research quality and compliance through the formulation and implementation of multi-dimensional quality assurance (QA) and quality control (QC) measures.

Main Responsibilities

  • Develop and maintain a robust QA system to ensure compliance with international standards and regulations.
  • Collaborate with cross-functional teams to identify and mitigate quality risks.
  • Design and implement quality control measures to ensure data integrity and accuracy.
  • Conduct internal audits and coordinate external audits to ensure compliance with regulatory requirements.
  • Develop and maintain standard operating procedures to ensure consistency and efficiency in clinical research operations.

Requirements

  • Bachelor's degree or above in Biological, Medical, Life Sciences, Quality Management, or related disciplines.
  • Minimum of 2 years' experience in clinical research quality management, monitoring, and/or project management/operations.
  • Good knowledge of Good Clinical Practice (GCP) and local/national/international regulations and guidelines related to clinical research.
  • Strong coordination and problem-solving skills, good interpersonal and communication skills, and commitment to quality and compliance.
  • Detail-minded, able to handle multiple concurrent tasks, self-motivated, and have a strong sense of responsibility.
  • Good command of written and spoken English and Chinese is a must.
  • Proficiency in Putonghua is a plus.

What We Offer

  • A highly competitive salary commensurate with qualifications and experience.
  • Contract-end gratuity and University contribution to a retirement benefits scheme at 10% of basic salary.
  • Annual leave and medical benefits.

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