Senior Manager, Quality Systems and Compliance, Japan

The opportunity:

The Senior Manager, Quality Systems & Compliance serves as the lead for Quality Systems and Compliance within the Revolution Medicines Japan Quality Assurance organization and is responsible for establishing, maintaining, operating, and continuously improving the Quality Management System (QMS) supporting the Japan Marketing Authorization Holder (MAH) organization.

As the process owner for Training, Document Management, Self-Inspection, and Inspection Readiness, this position ensures the effectiveness of quality systems and processes while maintaining alignment between local Japanese regulatory requirements and the Global Quality System.

In close collaboration with Global Quality and cross-functional stakeholders, 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).

Key responsibilities:

Quality Systems & Compliance

• 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.

Training Management

• Serve as the Training Responsible Person and 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.

Document Management

• 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.

Self-Inspection

• 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.

Inspection Readiness

• Lead regulatory inspection readiness activities and coordinate inspection-related activities.

• Serve as the Inspection Readiness Lead and maintain an inspection-ready state.

Required Skills, Experience and Education:

• 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.

Preferred Skills:

• Experience operating or improving a Quality Management System (QMS).

• Experience with training management, document management, and inspection readiness activities in a global pharmaceutical company.

• Experience establishing or implementing a Quality Management System (QMS).

• Experience managing Quality Metrics, KPIs, trend analysis, and Management Review activities.

• Experience establishing or managing GxP training programs.

• Experience establishing or implementing Quality Systems within a Marketing Authorization Holder (MAH) organization.

• Experience managing self-inspection, internal audit, or supplier audit programs.

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