Associate Director, Clinical Quality Assurance

Responsibilities

• Provide leadership and compliance support for sponsored clinical trials regarding SOPs and regulatory requirements (FDA, EU, ICH)
• Support the development and maintenance of Quality Systems complying with GCP standards
• Collaborate with clinical functions to provide GCP compliance support
• Participate in clinical study execution teams to enable risk-based quality management
• Perform quality reviews of clinical trial documents focusing on compliance and risk management
• Support the planning, conduct, and reporting of GCP audits with internal and external stakeholders
• Provide risk-based quality oversight and perform routine clinical vendor assessments
• Support inspection readiness activities including TMF and study documentation
• Coordinate investigations, root cause analysis, and CAPA management for quality issues
• Escalate identified issues to QA Management and leadership
• Support GCP audits and inspections by regulatory authorities or business partners

Requirements

• Bachelor’s degree in a scientific or technical discipline
• 10+ years of experience in GCP Quality within pharmaceutical or biotechnology industry
• 8 years of experience in audit management, inspection readiness, or CAPA management
• Extensive knowledge of ICH GCP and US FDA regulatory requirements
• Strong verbal and written communication skills
• Ability to manage multiple priorities and aggressive timelines
• Proficiency with Microsoft Office and computerized systems

Preferred Qualifications

• Knowledge of Computer System Validation

About the Company

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers.