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About the Role

The Sr Manager, Clinical QA serves as the 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.

Responsibilities

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.
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.
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.

Requirements

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.

Skills

GCP
GVP
GPSP
Quality Assurance
Quality Systems Management
Vendor Oversight
Regulatory Inspection Support
Inspection Readiness
Risk-based Quality Management
Continuous Improvement
Audits
Investigations
Deviation Management
CAPA Management
Quality Risk Management
Problem-solving
Communication
Stakeholder Management
Product Launch Readiness
Post-marketing Quality Activities
Quality Management Systems (QMS)
Outsourced/Virtual Development Models
Risk-Based Quality Management (RBQM) programs
Oncology Clinical Development
Electronic Trial Master File (eTMF) systems
GxP Auditor

Location

Japan

Work Type

Hybrid

Experience Level

Senior Manager
Minimum 3 years of quality assurance experience

Education Level

Bachelor's degree or higher

About the Company

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.

Equal Opportunity

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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.