Quality Systems Leader — Japan Compliance & Training

Revolution Medicines, Inc.; United States; On-site; USD 130,000 - 190,000; Full time

Job summary

Revolution Medicines seeks a Senior Manager of Quality Systems & Compliance to lead the QMS and compliance efforts for the Japan MAH organization. You will own training, document management, self-inspection, and inspection readiness, ensuring alignment with global standards and local regulatory requirements.

You will collaborate with Global Quality and cross-functional partners to drive continuous improvement, implement eQMS, and build a strong quality culture within the Japan QA team.

Qualifications

• Bachelor's degree or higher in a scientific discipline related to QA.
• Minimum 3 years of Quality Assurance experience in the pharmaceutical industry.
• Knowledge of GxP requirements and applicable regulations.
• Experience as a Business Process Owner or Key User for an 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.
• Ensure compliance with GxP requirements and regulatory standards.
• Coordinate training, self-inspection, and inspection readiness activities.

Skills

Quality Assurance

GxP knowledge

Regulatory experience

Cross-functional collaboration

English & Japanese bilingual

Education

Bachelor's degree

Pharmacy degree

Tools

eQMS software

Document management systems

Job description

Revolution Medicines seeks a Senior Manager of Quality Systems & Compliance to lead the QMS and compliance efforts for the Japan MAH organization. You will own training, document management, self-inspection, and inspection readiness, ensuring alignment with global standards and local regulatory requirements.

You will collaborate with Global Quality and cross-functional partners to drive continuous improvement, implement eQMS, and build a strong quality culture within the Japan QA team.