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 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. Japanese Translated: ポジション概要本ポジションは、Revolution Medicines Japan品質保証部門における品質システム・コンプライアンスの責任者として、日本の製造販売業者（MAH）業務を支える品質マネジメントシステム（QMS）の構築、運用、維持及び継続的改善を主導する。教育訓練、文書管理、自己点検及びInspection Readinessのプロセスオーナーとして、品質システムを構築し有効性を維持するとともに、日本固有の規制要求事項とグローバル品質システムとの整合性を確保する。また、Global Quality及び関連部門と密接に連携しながら、品質コンプライアンス、査察対応体制の維持、製品上市準備及び継続的改善活動を推進し、日本QA組織の発展及び品質文化の醸成に貢献する。日本における品質保証組織の立ち上げ段階においては、品質システム、教育訓練プログラム、文書管理プロセス及び品質イベント管理システム（eQMS）の導入、定着及び継続的改善を主導する。主な職務内容: Quality Systems & Compliance - 品質マネジメントシステム（QMS）の構築、運用及び継続的改善を主導する。 - 逸脱、CAPA、変更管理、教育訓練及び文書管理プロセスのプロセスオーナーとして管理・改善を行う。 - GxP要求事項、法規制及び社内基準への適合を確保する。 - Quality Metrics、KPI及びManagement Reviewを通じて品質システムの有効性を評価し、品質システム及びコンプライアンスプログラムの継続的改善を推進する。教育訓練 - 教育訓練責任者として、教育有効性評価およびスキル評価を管理し、教育訓練プログラムの構築、維持及び改善を実施する。 - GxP及び品質関連教育を実施又は支援する。 - 教育訓練の進捗及び記録を管理する。文書管理 - 文書管理責任者として文書管理プロセスを運営する。 - eQMSのBusiness Process Ownerとして活動し、SOP、品質関連記録及び各種文書のライフサイクル管理を行う。 - 国内外の法規制、ガイドライン及び業界動向を継続的にモニタリングし、品質システムへの適切な導入及び維持を主導する。自己点検 - 自己点検プログラムを構築、運営及び維持する。 - 年間計画の策定、実施、調整及び結果評価を行うとともに、CAPA/改善活動のフォローアップを実施する。 - 品質リスク及び改善機会をManagement Reviewにて報告する。 Inspection Readiness/査察準備 - 規制当局査察の準備活動を主導し、対応を調整する。 - Inspection Readiness Leadとして査察受審体制を維持する。必須スキル・経験・学歴: - 理系分野（薬学、化学、生物学、工学、理学、バイオテクノロジー等）における学士号以上 - 製薬業界における品質保証業務経験3年以上 - GxP及び関連法規制に関する知識及び経験 - eQMSのビジネスプロセスオーナー又は主要ユーザー経験 - 規制当局査察への対応経験 - グローバルかつクロスファンクショナルな環境で業務を遂行できる能力 - ビジネスレベルの英語力及びネイティブレベルの日本語力歓迎するスキル: - 品質マネジメントシステム（QMS）の運用又は改善経験 - グローバル製薬企業における教育訓練、文書管理及び査察受審体制整備経験 - 品質マネジメントシステム(QMS)の構築又は導入経験 - Quality Metrics、KPI管理、トレンド分析及びQuality Management Review運営経験 - GxP教育訓練プログラムの構築又は運営経験 - MAHにおける品質システムの構築・立上げ経験 - 自己点検、内部監査又は委託先監査プログラムの運営経験 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. 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Senior Manager, Quality Systems and Compliance, Japan

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