Work Flexibility: Hybrid or Onsite 【Main Responsibilities】 ISO 13485およびQMS省令に基づき、品質マネジメントシステム（QMS）の構築・維持・継続的改善をリードし、各部門と連携して実効性のある運用を推進する 品質文書の管理体制を整備し、SOPの作成・改訂および教育を通じて、適切な文書運用と現場への定着を促進する グローバルの手順や要求事項を日本のQMSへ適切に展開し、国内規制との整合を確保しながら導入・運用を支援する 内部監査の計画策定・実施および是正措置のフォローアップを通じて、QMSの運用状況を評価し、改善機会を特定する マネジメントレビューに向けた品質指標および運用実績を取りまとめ、経営層への報告および改善活動の推進を支援する NC/CAPAプロセスの運用を推進し、不適合・逸脱に対する原因分析、是正処置の立案と実行および有効性確認、予防処置の立案と実行および有効性確認を関連部門と連携して行う 購買管理プロセスにおいて供給者の評価・再評価を実施し、要件を満たすサプライヤーの管理および管理体制の維持・強化を行う 第三者認証機関、規制当局（東京都庁・PMDA）およびCorporateによる監査・調査に対応し、準備から指摘事項への改善対応まで一貫してリードする 【Job Experience/knowledge/Skills/Competency】 ・医療機器QMSにおける業務経験5年以上 ・海外との業務遂行経験（必須ではない） ・医薬品医療機器等法及び関連法規制、QMS省令、ISO13485の正しい理解 ・ISO13485:2016の内部監査員資格（必須ではない） ・問題解決能力、論理的思考力 ・利害関係者との円滑なコミュニケーション力 ・日本語、英語（主にメール、必要時会議）Travel Percentage: None...
Job Description Position Overview The Specialist, Quality Systems & Compliance is an individual contributor who supports key GQP Quality Assurance activities on behalf of the Marketing Authorization Holder (MAH). The role plans and executes assigned quality tasks, proposes improvements to
About the Role: This role is responsible for ensuring compliance with Ferrero Group quality requirements across the entire product value chain, from plant to consumer. The position focuses on implementing, monitoring, and continuously improving quality activities related to
Join our Worldwide Grocery Owned Brands team to shape the quality and safety of products that reach millions of customers across physical stores and online channels. In this role, youll partner with cross-functional teams to monitor product
Team Manager - Order Management We are looking for a dynamic and inclusive Team Manager to join our team in Tokyo. As a Team Manager, you will lead a team of approximately 10-12 staff, taking charge of
To get the best candidate experience, please consider applying for a maximum of 3 roles within 12 months to ensure you are not duplicating efforts. Job CategoryCustomer Success Job Details About Salesforce Salesforce is the #1
Role Overview As a Lead Frontend Engineer, you will own the end-to-end direction of our frontend applications used across convenience-store robotics operations. You will collaborate closely with business teams to clarify requirements, work with designers on
About Woven by Toyota Woven by Toyota is enabling Toyota’s once-in-a-century transformation into a mobility company. Inspired by a legacy of innovating for the benefit of others, our mission is to challenge the current state of
About Match Group Match Group is a leading global technology company focused on connecting people through a portfolio of iconic products, including Tinder, Pairs, and other brands used by millions of people around the world. We
Job Description SummaryLead Technology & System Innovation in Japan Patient Safety organization, driving innovation, system operations, data science, and document management to ensure full compliance with global and local pharmacovigilance regulations. This role is accountable for advancing digital transformation,
About Match Group Match Group is a leading global technology company focused on connecting people through a portfolio of iconic products, including Tinder, Pairs, and other brands used by millions of people around the world. We
This is what you will do: 【Manager, Japan Country Quality】 製造販売業者の信頼性保証部員として、当該役職者はGlobal AlxionのポリシーおよびSOPに従い、GQP QAグループを管理する。また、QMS管理業務、APJ手順書作成/制定、各品質協定規格締結/遵守、GMPコンプライアンス調査、製造所認定業務などの主要な活動を通じて、適正品質管理（GQP）およびGMDPの準拠を確保することを主たる責務とする。さらにAPJが製造販売業者として顧客クレーム対応も管理する。そのために社内外顧客、即ち、安全性管理部門、サプライチェーン、メディカル、薬事、CMC、営業・マーケティングなどと部門横断的に協働し、所轄当局や共同販売会社と連携・調整を行う。 You will be responsible for: ・開発品から市販後製品としてのGMDP/GQPプロセスのコンプライアンス管理 市販後製品の品質管理システム管理 製造販売業体制管理/主に品責・総責のサポート業務 市販後製品の品質関連業務 You will need to have: ・各種プロジェクト会議を主宰しリードする QA週例会議において、担当業務におけるトピックを速やかに報告する。 QA月例会議において、品質関連情報のトレンド分析を行い、必要な場合と是正を推進する。 QMS会議/主に変更・逸脱会議/事案に対する対応方針などの検討する Global組織とのコミュニケーション多数に参加し、APJの情報を報告・協議する。 We would prefer for you
Act as leading & responsible supervisor for Maersk Customs services to acquire JP AEO status within expected timelines, and lead AEO management team before/after AEO license acquisition. We Offer We offer you an exciting international career that
The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock
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企業概要 Turner & Townsend is a global professional services company with over 22,000 people in more than 62 countries. Working with our clients across real estate, infrastructure, energy and natural resources, we transform together delivering outcomes
Job Description: Business Overview Rakuten Groups basic management philosophy is to empower people and society through innovation”. We provide more than 70 diverse services, including EC services such as shopping malls and travel booking sites, financial services
Purpose & Overall Relevance for the Organization Drive, manage and deliver the Go To Market (GTM) strategy against global priorities; lead category management team to bring the strategy to life as well as manage local team sports
General Information Job Advert Title: PV Reporting and Information Management Professional Location: Nihonbashi, Tokyo Division: Regulatory Affairs and Pharmacovigilance Employment Class: Permanent Description 【About Astellas】 Astellas is a global life sciences company committed to turning innovative science
Job Description SummaryThe Logistics and Site Material & Quality Administrator is responsible for managing logistics, site material, and site-related and warehouse-related quality activities (i.e. shortage of materials or parts, defective material/parts handling, refilling of materials or parts, package