Clinical Quality Assurance Manager
Posted 6 Oct 2026
Advertised as “Senior Manager, Clinical Quality Assurance, Japan”
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 3+ yrs
- Management level
- Individual contributor
- Employment
- Remote
No salary listed for this role.
Field of studyBiology, Biotechnology, Chemistry, Engineering, Life Sciences, Pharmacy (or related)
Study levelBachelor's
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:
The Sr Manager, Clinical QA serves as the Revolution Medicines Japan quality lead for GCP, GVP and GPSP quality oversight, quality systems management, vendor oversight, regulatory inspection support and inspection readiness activities.
This role partners closely with Clinical Development, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Global Quality, CROs and external vendors to ensure compliance with applicable GCP, GVP, GPSP, and related regulatory requirements in Japan, while driving risk-based quality management and continuous improvement initiatives.
GCP Quality Assurance
-
Lead and support regulatory inspections and inspection readiness activities.
-
Provide risk-based quality oversight of CROs, laboratories, eTMF providers, and other clinical vendors.
-
Partner with Clinical Development to promote GCP compliance.
-
Perform quality reviews of key documents, records, and operational processes.
-
Plan, conduct, and follow up on audits, inspections, and vendor audits.
-
Support investigations, deviation management, CAPA activities, and root cause analyses.
-
Provide quality guidance and support to clinical study teams
GVP Quality Assurance
-
Provide quality oversight of post-marketing surveillance activities conducted in accordance with GPSP requirements.
-
Establish, maintain, and continuously improve GPSP-related SOPs and quality systems.
-
Perform quality reviews of processes, records, and deliverables associated with post-marketing surveillance activities.
-
Assess and manage GPSP-related deviations, CAPAs, quality events, and quality risks.