Director of Clinical Quality Oversight

Job Summary

Leading enterprise-wide quality intelligence and portfolio risk surveillance, the full-time remote Director of Clinical Quality Oversight will manage quality oversight activities across Clinical Development, identify emerging quality signals, and enhance compliance through data-driven analytics.

Key Responsibilities

• Lead enterprise-level quality surveillance activities and identify systemic quality risks across clinical studies
• Develop and maintain portfolio-level dashboards and analytics to support quality oversight and leadership visibility
• Provide leadership for vendor quality management and ensure risk-based oversight frameworks are implemented effectively

Required Qualifications

• Bachelor's degree in Life Sciences or related field required; advanced degree preferred
• Minimum of 10 years of experience in GCP Quality Assurance or related roles within the pharmaceutical or biotechnology industry
• Demonstrated experience in leading enterprise-level quality oversight and implementing risk-based quality management frameworks
• Strong proficiency in quality metrics, dashboards, and analytics, with the ability to interpret complex data
• Deep knowledge of ICH GCP, FDA, EMA, and global clinical regulatory requirements