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
A&PS Project Manager This role has been designed as Hybrid with a requirement that you will work on average 2 days per week from an HPE office. Who We Are: Hewlett Packard Enterprise is the global edge-to-cloud
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
Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, Regulatory Submission Project Management to join our Regulatory Operations team, supporting our
Job TitlePortfolio Manager Job Description SummaryThis position requires to effectively deliver Transactions aligning with the strategy for Real Estate portfolio and its contract in Japan. The resource will work closely along with the RDC (Real Estate &
Amazon Web Services (AWS) Security is looking for an experienced APAC Senior Trade Compliance Manager to support our business on a broad range of import and export compliance matters. You will interact with AWS Security, Development, Datacenter
Position/ Title: Senior Design Manager, Product Design (potential design center lead) Coalition & Brand: VF Japan Function: Product Design Geographic Scope: Global/Asia/Japan Reporting Manager: Product Design Director (TDC Lead), VF Japan Role & Responsibilities: Position Definition (Key Purpose
TrustYou is a leading AI-driven hospitality platform dedicated to transforming guest experiences and empowering businesses to thrive. With a multicultural team of over 150 professionals working remotely across the globe, we are on a mission to
Anduril Industries is a defense technology company with a mission to transform U.S. and allied military capabilities with advanced technology. By bringing the expertise, technology, and business model of the 21st century’s most innovative companies to
Overview MongoDB is hiring a Manager, Employee Experience Japan (individual contributor) to join our APAC Employee Experience organization. The role will report to the Head of HR, APAC and will be responsible for scaling business processes while
Are you ready to be part of a pioneering force in the language services and technology industry? At TransPerfect, we go beyond traditional translation; we are fundamentally a software company. Our language solutions are designed with
We’re in an unbelievably exciting area of tech and are fundamentally reshaping the data storage industry. Here, you lead with innovative thinking, grow along with us, and join the smartest team in the industry. This type
企業概要 About AbbVie AbbVies mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on peoples
Celonis is the global leader in Process Intelligence and the pioneer of Process Mining technology. As one of the world’s fastest-growing enterprise SaaS companies, we are changemakers pushing the boundaries of what’s possible. We invest heavily
About BJAK The original mission of BJAK is we believe people deserve smarter ways to plan, save and grow their money. This is the origin of our name. Started in 2019, we built the first mobile-first,
About Anthropic Anthropic’s mission is to create reliable, interpretable, and steerable AI systems. We want AI to be safe and beneficial for our users and for society as a whole. Our team is a quickly growing
About BJAK The original mission of BJAK is we believe people deserve smarter ways to plan, save and grow their money. This is the origin of our name. Started in 2019, we built the first mobile-first,
About BJAK The original mission of BJAK is we believe people deserve smarter ways to plan, save and grow their money. This is the origin of our name. Started in 2019, we built the first mobile-first,
About BJAK The original mission of BJAK is we believe people deserve smarter ways to plan, save and grow their money. This is the origin of our name. Started in 2019, we built the first mobile-first,
About BJAK The original mission of BJAK is we believe people deserve smarter ways to plan, save and grow their money. This is the origin of our name. Started in 2019, we built the first mobile-first,