Associate Director, Clinical Quality Assurance

A minimum of 10+ years of experience in GCP Quality in the pharmaceutical or biotechnology industry.

8 years in any of the following areas: audit or audit management experience, inspection readiness, Deviation/CAPA management, or related quality management system responsibilities.

Extensive knowledge of ICH GCP, other relevant ICH guidelines and regulatory requirements (minimally US FDA) regarding applicable drug development regulations.

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Revolution Medicines is seeking an Associate Director, Clinical Quality Assurance, who will play a key role within Quality Assurance and is responsible for providing leadership and compliance support for RevMed sponsored clinical trials with respect to RevMed’s Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country-specific), and current industry standards and practices.

Support the development and maintenance of applicable Quality Systems and procedures that comply with applicable GCP standards and guidelines.

Collaborate with clinical functions (e.g., Clinical Operations, Clinical Development) to provide GCP compliance support.

Participate in clinical study execution teams (CSETs) to enable risk-based quality management and a culture of quality and open dialogue.

Perform quality review of clinical trial documents with a focus on compliance / regulatory requirements and risk management.

Collaborate with internal stakeholders, external auditors, and auditees to support the planning, preparation, conduct, reporting, and closure of GCP audits.