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About the Role

The Senior Manager, Quality Systems & Compliance serves as the lead for Quality Systems and Compliance within the Revolution Medicines Japan Quality Assurance organization. This role is responsible for establishing, maintaining, operating, and continuously improving the Quality Management System (QMS) supporting the Japan Marketing Authorization Holder (MAH) organization. The position ensures the effectiveness of quality systems and processes while maintaining alignment between local Japanese regulatory requirements and the Global Quality System. This role supports Quality Compliance, Inspection Readiness, Product Launch Readiness, and Continuous Improvement initiatives, while contributing to the growth of the Japan QA organization and fostering a strong quality culture. During the establishment phase of the Japan QA organization, this position will play a key role in implementing, embedding, and continuously improving Quality Systems, Training Programs, Document Management processes, and electronic Quality Management Systems (eQMS).

Responsibilities

Lead the establishment, operation, maintenance, and continuous improvement of the Quality Management System (QMS).
Serve as Process Owner for Deviation Management, CAPA, Change Control, Training, and Document Management processes, ensuring effective governance and continuous improvement.
Ensure compliance with applicable GxP requirements, regulatory requirements, and company standards.
Evaluate the effectiveness of the Quality System through Quality Metrics, KPIs, and Management Review activities, and drive continuous improvement of Quality Systems and Compliance Programs.
Serve as the Training Responsible Person and manage training effectiveness assessments and competency evaluations, while establishing, maintaining, and improving the training program.
Deliver or support GxP and quality-related training.
Manage training status and training records.
Serve as the Document Management Responsible Person and manage the document control process.
Act as the Business Process Owner for the eQMS and manage the lifecycle of SOPs, quality records, and controlled documents.
Continuously monitor related regulations, guidelines, and industry trends, and lead the implementation and maintenance of applicable requirements within the Quality System.
Serve as Self-Inspection Responsible Person and establish, manage and maintain the self-inspection program.
Develop annual self-inspection plans, coordinate and execute self-inspections, evaluate results, and follow up on CAPAs and improvement activities.
Report quality risks and improvement opportunities through Management Review.
Lead regulatory inspection readiness activities and coordinate inspection-related activities.
Serve as the Inspection Readiness Lead and maintain an inspection-ready state.

Requirements

Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Engineering, Science, Biotechnology, or a related scientific discipline.
Minimum 3 years of Quality Assurance experience in the pharmaceutical industry.
Knowledge of and experience with GxP requirements and applicable regulations.
Experience serving as a Business Process Owner or Key User for an eQMS.
Experience supporting regulatory inspections.
Ability to work effectively in global and cross-functional environments.
Business-level English and native-level Japanese language proficiency.

Skills

Quality Systems
Compliance
Quality Management System (QMS)
Japan Marketing Authorization Holder (MAH)
Training Management
Document Management
Self-Inspection
Inspection Readiness
Deviation Management
CAPA
Change Control
GxP
Quality Metrics
KPIs
Management Review
eQMS
Business Process Owner
Key User
Regulatory Inspections
Global and cross-functional collaboration
English proficiency
Japanese proficiency
Operating or improving a Quality Management System (QMS)
Training management
Document management
Inspection readiness activities
Establishing or implementing a Quality Management System (QMS)
Managing Quality Metrics
KPI trend analysis
Management Review activities
Establishing or managing GxP training programs
Establishing or implementing Quality Systems within a Marketing Authorization Holder (MAH) organization
Managing self-inspection programs
Managing internal audit programs
Managing supplier audit programs

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.