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Revolution Medicines · Remote

# Senior Manager, Clinical Quality Assurance, Japan

Remote Remote Manager or lead Healthcare & Clinical 

Listed on Revolution Medicines’s official careers site. Posted October 6, 2026. Check that it is still open and apply there.
[Apply on Revolution Medicines’s careers site →](https://www.revmed.com/careers-list/?gh_jid=8013750003)

[OpenNash Jobs](https://jobs.opennash.com/) / [Revolution Medicines](https://jobs.opennash.com/companies/revolution-medicines/) / Senior Manager, Clinical Quality Assurance, Japan

## Job description

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.

Support GPSP-related audits and regulatory inspections. Oversee vendors supporting post-marketing surveillance activities and monitor performance. Collaborate with Pharmacovigilance, Medical Affairs, and Regulatory Affairs to ensure compliance with applicable requirements. Quality Systems & Inspection Readiness Support the development, maintenance, and continuous improvement of the Japan Quality Management System (QMS).

Develop, maintain, and manage SOPs and related quality documents. Monitor regulatory developments and incorporate applicable requirements into quality systems. Escalate significant quality risks and issues that may impact patient safety. Establish and maintain inspection readiness programs and inspection management processes. Promote a culture of quality and continuous improvement across the organization.

### Required Skills, Experience and Education

Bachelor's degree or higher in Pharmacy, Life Sciences, Biology, Chemistry, Engineering, Biotechnology, or a related scientific discipline. Minimum 3 years of quality assurance experience related to GCP, GVP and/or GPSP within the pharmaceutical industry. Knowledge of GCP, GVP, GPSP, applicable regulations and industry best practices. Experience supporting regulatory inspections and inspection readiness activities. Experience overseeing CROs, PV vendors, post-marketing surveillance vendors, and other GxP service providers.

Experience with audits, investigations, deviation management, CAPA management, and quality risk management. Problem-solving, communication, and stakeholder management skills. Ability to manage multiple priorities in a global, cross-functional environment. Business-level English proficiency and native-level Japanese proficiency.

### Preferred Skills

Experience supporting product launch readiness and post-marketing quality activities within an MAH organization. Experience establishing, maintaining, or improving Quality Management Systems (QMS). Experience working within outsourced or virtual development models. Experience implementing Risk-Based Quality Management (RBQM) programs. Experience supporting oncology clinical development programs. Experience using electronic Trial Master File (eTMF) systems and supporting TMF inspection readiness activities.

Experience as a GxP auditor, including internal, vendor, and supplier audits. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. #LI-YO1 #LI-Hybrid We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines.

These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @revmed.com email address.

If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to careers@revmed.com so we can share these impersonations with our IT team for tracking and awareness.

## At a glance
- Posted by the employer: Oct 6, 2026
- First seen by OpenNash: Oct 11, 2026
- Last checked: Oct 18, 2026
- Listed for: 12 days
- Location: Remote
- Work arrangement: Remote[Apply on Revolution Medicines’s careers site →](https://www.revmed.com/careers-list/?gh_jid=8013750003)

## More jobs at Revolution Medicines

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### [Associate Director, FP&A, Japan](https://jobs.opennash.com/companies/revolution-medicines/jobs/ac0c633882f002c2bd60/)

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### [Associate Director, GxP Quality Assurance, Japan](https://jobs.opennash.com/companies/revolution-medicines/jobs/e7b21815a9e2c2d6ec59/)

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### [Associate Director, Insight & Analytics, Japan](https://jobs.opennash.com/companies/revolution-medicines/jobs/229a7b7da250ac138717/)

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### [Associate Director, New Product Planning & Compound Strategy, Lung Cancer and Companion Diagnostics, Japan](https://jobs.opennash.com/companies/revolution-medicines/jobs/93540ea612c5c0cac82e/)

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