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Associate Director, Clinical Quality Assurance (Audits & Inspections) - Remote

Posted 2 days ago

Overview

The Associate Director of Clinical Quality Assurance will provide GCP compliance oversight and support for clinical studies, ensuring adherence to regulatory requirements and leading audits.

In Short

  • Support Clinical Quality Assurance function.
  • Provide GCP compliance oversight.
  • Manage health authority inspections and audits.
  • Lead audits of investigator sites and clinical vendors.
  • Develop/revise Policies, SOPs, and Work Instructions.
  • Mentor junior CQA members.
  • Participate in quality and compliance initiatives.
  • Maintain expertise in global GCP regulations.
  • Analyze compliance risks and propose solutions.
  • Collaborate with stakeholders on quality issues.

Requirements

  • 8+ years of experience in GCP related discipline.
  • Expert knowledge of global GCP and drug development regulations.
  • Experience leading audits and managing inspection readiness.
  • Strong communication and interpersonal skills.
  • Ability to influence and negotiate across teams.
  • Strong analytical and strategic assessment skills.
  • Flexibility with a risk-based approach to quality.
  • Bachelor’s degree in medical or health sciences.
  • Ability to travel up to 30% domestically and internationally.
  • Proficiency in MS Office and Veeva Vault.

Benefits

  • Competitive salary range of $185,000 - $195,000 annually.
  • Participation in stock programs.
  • Performance-based bonus opportunities.
  • Comprehensive benefits package.
  • Equal Opportunity Employer commitment.

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