Associate Director/Director, Quality Assurance

Flexible, United States
Posted 3 years ago

Main Responsibilities:

Lead and provide overall quality assurance strategies for Ascentage clinical development. Define and execute overall quality assurance activities in collaboration with Clinical Operation, pharmacovigilance and CMC. Have thorough knowledge of GCP, EU Directives, ICH, and are familiar with current and emerging US and global guidelines and regulations and apply in the company’s clinical studies for the development of quality risk mitigation strategies. Perform risk assessments to identify audit targets, conduct internal and vendor audits, develop and maintain audit tools, checklists and plans, and author or review audit reports and other audit-related documentation. Ensures timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management. Define and implement the health authority inspection strategies in support of the submissions and GCP compliance.

Minimum Requirements:

  • BS in Sciences required; advanced degree highly preferred
  • Must have 8+ years of pharmaceutical or biotech industry experience
  • Must have 5+ years of hands-on quality assurance lead experience
  • 3+ years of clinical trial monitoring and/or pharmacovigilance experience
  • Experience in leading internal and vendor audit is essential
  • Experience in leading FDA and other health authorities’ inspection are highly preferred


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