Global Clinical Quality Director

Job Summary

Driving clinical quality initiatives, the full-time remote Global Clinical Quality Director will ensure protocol assessments, mentor operational teams, and oversee risk management to enhance the quality of clinical trials for biotech, medtech, and specialty pharma companies.

Key responsibilities

• Ensure individual protocol assessments and manage clinical quality risks throughout the project lifecycle
• Support and mentor operational teams in risk assessment and implementation of governance and risk management policies
• Oversee documentation of observations and investigate trends and issues for root cause analysis

Required qualifications

• Bachelor's degree in Life Sciences or related field
• 5-7 years in a lead Operations role at a clinical site/system research facility and 5-7 years of industry experience in a Quality leadership role
• Strong knowledge of ICH-GCP, FDA, ISO, and other global regulatory requirements
• Expertise in Risk-Based and Critical to Quality Strategies at the clinical trial level
• Demonstrated leadership and mentorship capabilities with a proactive, Quality by Design approach