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...
Role Overview The Real-Time Market Data (RTMD) team is responsible for operating and supporting the firms mission-critical market data infrastructure that powers electronic trading, risk management, and front-office applications globally. This position primarily supports North American trading
Head of Client Strategy and Relationship Management is a senior level position responsible for a portfolio of platinum clients across the team. This role integrates subject matter and industry expertise across operations. It requires an in-depth understanding
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
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
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
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
Firm Risk Management Firm Risk Management (FRM) supports Morgan Stanley to achieve its business goals by partnering with business units across the Firm to realize efficient risk-adjusted returns, acting as a strategic advisor to the Board and protecting
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
Who we are looking for As a Relationship Manager within the State Street Investment Management (Japan) Intermediary team, your role is to achieve sales targets by ensuring our clients and prospects receive the most relevant investment solutions
LocationRoppongi Hills Mori Tower - 17F, 6-10-1 Roppongi, Business - Global Client Group Brookfield is one of the world’s largest alternative asset managers, distinguished by a 100+ year heritage of owning and operating assets and businesses
We help the world run better At SAP, we keep it simple: you bring your best to us, and well bring out the best in you. Were builders touching over 20 industries and 80% of global
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our
About us Founded in 2017, Wayve is the leading developer of Embodied AI technology. Our advanced AI software and foundation models enable vehicles to perceive, understand, and navigate any complex environment, enhancing the usability and safety
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
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
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