Massachusetts Licensed Clinical Quality Director

Job Summary

A company is looking for an Associate Director Clinical Program Quality.

Key Responsibilities

• Provide quality assurance oversight for global clinical research programs to ensure ongoing inspection readiness
• Serve as a strategic quality partner to Clinical Program Teams and key stakeholders, offering risk-based GCP quality and compliance advice
• Lead investigations into major quality issues, serious GCP breaches, and scientific misconduct, including root cause analysis and CAPA development

Required Qualifications

• Bachelor's degree required
• At least 10 years of experience in the pharmaceutical, biotechnology, or related healthcare industry
• At least 7 years of GCP-related Quality Assurance or relevant clinical trial experience
• Strong knowledge of ICH GCP and applicable global clinical development regulations and guidance
• Advanced expertise in planning, conducting, and reporting audits