Senior Manager, Product Quality Assurance, Japan

The Opportunity:

The Senior Manager, Product Quality Assurance serves as a Product Quality Representative within the Japan Quality Assurance organization and is responsible for executing and coordinating day-to-day Product Quality Assurance operations that support the Japan Marketing Authorization Holder (MAH) organization.

For assigned products, this role drives Quality Assurance activities throughout the product lifecycle and leads product quality activities including product release support, quality information management, product complaint handling, recall management, GDP-related quality activities, regulatory inspection support, and product launch readiness activities.

Working closely with internal and external stakeholders, the position promotes the effective operation of quality processes, quality event investigations, quality risk assessments, and continuous improvement initiatives, while contributing to the development and growth of the Japan Quality Assurance organization.

Key responsibilities:

Quality System and Process Development

• Participate in the establishment, implementation, operation, and continuous improvement of Quality Systems and Quality Processes within the Quality Assurance organization.

• Drive the effective execution of quality processes within assigned areas of responsibility.

• Maintain an effective cross-training and backup structure within the QA organization, as appropriate.

Product Launch Readiness

• Lead Product Quality Assurance activities supporting product launch readiness in Japan.

• Support the implementation and sustainable operation of Japan-specific regulatory requirements within the Global Quality System throughout the product lifecycle.

External Partner Management

• Support quality audits of external partners.

• Support the establishment, maintenance, and periodic review of Quality Technical Agreements (QTAs) with Contract Manufacturing Organizations (CMOs), logistics providers, warehouses, call centers and other GxP service providers.

• Conduct routine quality reviews and quality oversight activities for outsourced operations.

Market Release and Product Quality Assurance

• Review and/or approve quality records as delegated and in accordance with established procedures supporting product release activities.

• Support final quality decisions regarding significant quality events and product disposition decisions.

• Ensure that quality assessments are completed appropriately to support product release decisions.

Quality Event Management

• Lead product Deviations, CAPAs, Change Controls, Quality Information, Product Quality Complaints and other quality events related to assigned products.

• Conduct investigations, root cause analyses, and quality risk assessments.

• Ensure timely escalation and follow-up of significant quality issues.

Quality Metrics

• Collect data and prepare inputs for Annual Product Reviews (APRs) and Management Reviews.

• Conduct trend analyses and identify potential quality risks and improvement opportunities.

• Drive continuous improvement initiatives based on quality metrics and quality performance trends.

Regulatory Inspection Support

• Lead inspection readiness activities within assigned areas of responsibility.

• Support and participate in regulatory inspections and audits.

• Prepare and maintain documentation required for inspection and audit activities

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 within the pharmaceutical industry.

• Knowledge of and experience with GQP, GMP, GDP, and applicable pharmaceutical regulations.

• Experience supporting regulatory inspections and audits.

• Experience working with GxP service providers, such as Contract Manufacturing Organizations (CMOs), logistics providers, warehouses and call centers.

• Practical experience with product release, Deviation management, CAPA, Change Control, Quality Information and Product Quality Complaints management.

• Strong problem-solving and cross-functional collaboration skills.

• Ability to work effectively in global and cross-functional environments.

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

Preferred Skills:

• Experience serving as a Product Quality Lead or Product Quality Representative for assigned products within a Japan MAH organization.

• Experience supporting product launch readiness and post-marketing Quality Assurance activities within a Japan MAH organization.

• Experience establishing or improving Quality Systems.

• Experience establishing, managing, and maintaining Quality Technical Agreements (QTAs) and outsourced quality activities.

• Experience collaborating with Pharmacovigilance, Regulatory Affairs, and Supply Chain functions.

• Experience supporting regulatory inspections and audits.

• Experience as a GxP auditor

• Experience in CMC-related functions, including API process development, formulation development, analytical method development, or CMC regulatory affairs.

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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製品品質保証のリーダーとして、製造販売業者（MAH）組織を支える日常的な製品品質保証オペレーションの実行及び調整を担う。

担当製品において、製品ライフサイクル全体を通じた品質保証活動を推進し、市場出荷判定、品質情報、品質苦情、回収対応、GDP関連活動、規制当局査察対応及び製品上市準備活動を主導する。

また、部門内及び社内外の関係者と連携しながら、品質プロセスの運用、品質イベント調査、品質リスク評価及び継続的改善活動を推進し、日本QA組織の発展に貢献する。

主な職務内容:

• 品質システム及びプロセスの構築：品質保証部門におけるシステム及びプロセスの構築・運用及び継続的改善に参画し、担当領域における品質プロセスの適切な運用を推進する。必要に応じてQA組織内の相互バックアップ体制を維持する。

• 製品上市準備：日本での製品上市準備活動を主導する。日本固有の規制要件についてグローバル品質システムへの適切な導入及び運用定着を支援する。製品ライフサイクル全体を通じて必要な品質要件が維持されるよう推進する。

• 外部委託先管理：製造委託先、保管・輸送、コールセンター等への監査実施ならびに品質契約(QTA)の締結、維持及び定期見直しを支援し、定期的な品質レビュー及び品質監督活動を実施する。

• 市場出荷判定及び製品品質保証：市場出荷判定において、記録類をレビュー又は承認する。重要な品質イベント及び製品の出荷可否に関する最終判断を支援する。

• 品質イベント管理：担当製品に関する逸脱、変更管理、CAPA、品質情報及び品質苦情対応を主導する。根本原因分析、調査及び品質リスク評価を実施する。重大な品質課題について随時エスカレーション及びフォローアップを実施する。

• 品質指標(Quality Metrics)：Annual Product Reviews (APRs)及びManagement Reviewに必要なデータを収集し、トレンド分析を行い、課題の特定及び継続的改善活動を推進する。

• 規制当局査察対応：担当する領域における査察準備活動を主導し、査察対応及び監査対応を実施する。

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

• GQP、GMP、GDP及び関連法規制に関する知識及び経験

• 規制当局監査・査察への対応経験

• 外部委託先（製造委託先、保管・輸送業者、コールセンター等）との品質関連業務経験

• 市場出荷判定、逸脱、CAPA、変更管理、品質情報等に関する実務経験

• 問題解決能力及び組織横断的な調整能力

• 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:

• MAHにおいて担当製品の品質責任者としての経験

• 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

• 品質システムの構築又は改善経験

• 規制当局監査・査察対応経験

• QTAの締結・管理及び委託先品質管理経験

• 安全性部門、薬事部門、サプライチェーン部門との協働経験

• GxP監査員としての経験

• CMC関連業務経験（原薬プロセス開発、製剤開発、分析法開発、CMC薬事等）

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