Director of Quality Assurance & Compliance – Clinical Trials

About This Role

The Quality Assurance & Compliance Director will oversee QA operations for clinical trials at a key site, ensuring compliance with FDA regulations, GCP, and internal SOPs. This role involves leading audits, managing QA/QC staff, and facilitating regulatory inspections to maintain quality standards.

Responsibilities

• Lead and conduct audits of clinical trial documents, Case Report Forms, and Clinical Study Reports to ensure compliance with FDA regulations, GCP, and internal SOPs
• Manage and mentor QA/QC staff, ensuring training completion and adherence to quality standards
• Facilitate Sponsor audits, regulatory inspections, and CAPA investigations, resolving compliance issues promptly
• Support quality initiatives across multiple clinical sites and strengthen the company-wide Quality Management System (QMS)
• Supervise and guide QA/QC staff in alignment with organizational compliance goals

Requirements

• 10+ years experience in clinical research, pharmaceutical, or medical device industries
• Strong knowledge of FDA regulations, ICH/GCP guidelines, and clinical trial compliance
• Extensive experience managing audits and CAPA programs
• Proven leadership and team management skills
• Ability to travel and relocate as required to support multiple sites

Qualifications

• 10+ years’ experience in clinical research, pharmaceutical, or medical device industries

Benefits