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

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.