Senior Manager, Clinical Quality Assurance, Japan

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 Sr Manager, Clinical QA serves as the Revolution Medicines 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.

GCP Quality Assurance

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Lead and support regulatory inspections and inspection readiness activities.

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Provide risk-based quality oversight of CROs, laboratories, eTMF providers, and other clinical vendors.

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Partner with Clinical Development to promote GCP compliance.

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Perform quality reviews of key documents, records, and operational processes.

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Plan, conduct, and follow up on audits, inspections, and vendor audits.

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Support investigations, deviation management, CAPA activities, and root cause analyses.

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Provide quality guidance and support to clinical study teams

GVP Quality Assurance

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Provide quality oversight of post-marketing surveillance activities conducted in accordance with GPSP requirements.

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Establish, maintain, and continuously improve GPSP-related SOPs and quality systems.

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Perform quality reviews of processes, records, and deliverables associated with post-marketing surveillance activities.

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Assess and manage GPSP-related deviations, CAPAs, quality events, and quality risks.

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Support GPSP-related audits and regulatory inspections.

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Oversee vendors supporting post-marketing surveillance activities and monitor performance.

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Collaborate with Pharmacovigilance, Medical Affairs, and Regulatory Affairs to ensure compliance with applicable requirements.

Quality Systems & Inspection Readiness

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Support the development, maintenance, and continuous improvement of the Japan Quality Management System (QMS).

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Develop, maintain, and manage SOPs and related quality documents.

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Monitor regulatory developments and incorporate applicable requirements into quality systems.

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Escalate significant quality risks and issues that may impact patient safety.

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Establish and maintain inspection readiness programs and inspection management processes.

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Promote a culture of quality and continuous improvement across the organization.

Required Skills, Experience and Education

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Bachelor's degree or higher in Pharmacy, Life Sciences, Biology, Chemistry, Engineering, Biotechnology, or a related scientific discipline.

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Minimum 3 years of quality assurance experience related to GCP, GVP and/or GPSP within the pharmaceutical industry.

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Knowledge of GCP, GVP, GPSP, applicable regulations and industry best practices.

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Experience supporting regulatory inspections and inspection readiness activities.

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Experience overseeing CROs, PV vendors, post-marketing surveillance vendors, and other GxP service providers.

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Experience with audits, investigations, deviation management, CAPA management, and quality risk management.

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Problem-solving, communication, and stakeholder management skills.

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Ability to manage multiple priorities in a global, cross-functional environment.

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Business-level English proficiency and native-level Japanese proficiency.

Preferred Skills

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Experience supporting product launch readiness and post-marketing quality activities within an MAH organization.

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Experience establishing, maintaining, or improving Quality Management Systems (QMS).

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Experience working within outsourced or virtual development models.

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Experience implementing Risk-Based Quality Management (RBQM) programs.

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Experience supporting oncology clinical development programs.

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Experience using electronic Trial Master File (eTMF) systems and supporting TMF inspection readiness activities.

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Experience as a GxP auditor, including internal, vendor, and supplier audits.

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GCP, GVP及びGPSP領域の品質保証（QA）リードとして、品質システム運営及び委託先管理、関連する規制当局調査・査察対応、査察準備活動をリードする。

また臨床部門、安全性部門、薬事部門、Medical Affairs、 Global Quality、CRO、ベンダー等と密接に連携し、日本国内におけるGCP、GVP、GPSP及び関連法規制へのコンプライアンスを確保するとともに、リスクベース品質マネジメント及び継続的改善を推進する。

主な職務内容:

GCP 品質保証

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規制当局査察対応及び準備活動の主導・支援

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CRO、検査機関、eTMFベンダー等に対するリスクベースの品質管理及び監督

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臨床部門との連携によるGCPコンプライアンス推進

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重要文書、記録、業務プロセスの品質レビュー

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監査、査察及びベンダー監査の準備・実施及びフォローアップ

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品質事象、逸脱、CAPA及び根本原因分析の支援

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治験チームへの品質面からの助言及びサポート

GVP 品質保証

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国内の安全性業務及びPVベンダーに対する品質保証活動

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GVP関連SOP及び品質システムの構築、維持及び継続的改善

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安全性業務に関する逸脱、CAPA、品質指標及び品質イベントの評価・管理

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GVP査察及び監査対応

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安全管理部門との連携による品質・コンプライアンスリスク管理

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PV委託先の選定、評価、監督及びパフォーマンス管理

GPSP 品質保証

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GPSPに基づく製造販売後調査及び関連業務に対する品質保証活動

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GPSP関連SOP及び品質システムの構築、維持及び継続的改善

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製造販売後調査に関する業務プロセス、記録及び成果物の品質レビュー

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GPSPに関連する逸脱、CAPA、品質イベント及び品質リスクの評価・管理

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GPSP関連監査及び規制当局査察への対応支援

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製造販売後調査業務の委託先管理及びパフォーマンス監督

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安全性部門、メディカルアフェアーズ部門及び薬事部門との連携によるコンプライアンス確保

品質システム及び査察対応

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QMSの構築、運用及び継続的改善支援

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SOPの作成及び維持・管理

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規制動向のモニタリング及び品質システムへの反映

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重大品質リスク及び患者安全に影響する事項のエスカレーション

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査察対応体制及びInspection readinessプログラムの構築・維持

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品質文化及び継続的改善活動の推進

必須スキル・経験・学歴 :

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理系分野（薬学、化学、生物学、工学、バイオテクノロジー等）における学士号以上

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製薬業界におけるGCP, GVP又は GPSPに関する品質保証業務経験3年以上

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GCP、GVP、GPSP及び関連法規制及び業界のベストプラクティスに関する知識

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規制当局査察への対応及び査察準備活動（Inspection Readiness）の経験

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CRO管理、PVベンダー、製造販売後調査委託先等の管理経験

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監査、逸脱・品質事象調査、CAPA管理及び品質リスクマネジメントの経験

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問題解決能力、コミュニケーション能力及びステークホルダーマネジメント能力

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グローバルかつクロスファンクショナルな環境において、複数の優先事項を管理できる能力

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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 :

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MAHにおける 製品上市準備及び上市後品質保証活動の経験

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品質マネジメントシステム （QMS）の構築、維持又は継続的改善経験

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アウトソース型の臨床開発モデルにおける業務経験

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リスクベース品質マネジメント（Risk-Based Quality Management: RBQM）の運用経験

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オンコロジー（がん領域）における臨床開発プログラムの支援経験

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電子Trial Master File（eTMF）システムの利用経験及びTMF査察準備活動の経験

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GxP監査員としての経験

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