Clinical Quality Assurance

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS. Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.

The Opportunity:

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.

• Provide risk-based quality oversight for clinical trial activities and perform routine clinical vendor assessments.

• Provide support for Inspection Readiness activities (e.g., TMF activities, study documentation).

• Assess and coordinate activities relevant to potential quality issues associated with GCP and clinical trial conduct including but not limited to investigations, and root cause analysis, CAPA planning and management.

• Escalate identified issues to QA Management and other relevant leadership as needed in a timely manner.

• Enable other assigned GCP or GXP related tasks, as appropriate.