Total 8 Manager level Quality Assurance / Control job vacancies in Toranomon, Tokyo

Our Tokyo Autonomous Forklift Solutions team is hiring a Safety Compliance Manager capable of defining and managing the safety life cycle of the autonomous forklift solution (AFL) to provide utmost safety while operating under challenging warehouse conditions and executing complex processes involving multi-robots.

The mission is to build safe and scalable AFL solutions that support end-to-end processes in the warehouse. 

Key Responsibilities: 

• Safety Lifecycle Management: Lead, manage, and update the safety lifecycle of the autonomous forklift, including safety goal setting, safety requirements, risk assessment, safety validation, and safety auditing. 

• Standards Compliance: Ensure compliance with relevant safety standards such as ISO 12100 or equivalent JISD standards. 

• Risk Assessment: Conduct thorough risk assessments to identify potential hazards and implement appropriate safety measures. 

• Safety Validation: Develop and execute safety validation protocols, ensuring that all safety-related functions are thoroughly tested and verified. 

• Documentation and Reporting: Prepare detailed safety documentation and reports for internal and external stakeholders, including safety case reports, compliance documentation, and risk assessment records. 

• Cross-Functional Collaboration: Work closely with product development, quality assurance and deployment teams to integrate and update safety into the product design, development and deployment process. 

• Auditing: Conduct regular safety audits and inspections to ensure ongoing compliance with safety standards and regulations. 

• Training and Development: Provide safety training and guidance to the engineering and development teams to promote a culture of safety within the organization. 

Minimum Qualifications: 

• Ownership: Strong drive to own the safety management outcome from defining problems to implementing with minimum supervision.  

• Experience: 3 to 5 years of experience in product development and safety lifecycle management, specifically in automation, mechatronics, robotics, or related fields. 

• Attention to Detail: Demonstrated ability to maintain a high level of accuracy and attention to detail in safety assessments and documentation while assuring comprehensiveness 

• Knowledge of Standards: Familiarity with safety standards such as ISO 12100 or equivalent JISD standards.. 

• Technical Skills: Strong understanding of safety principles, risk assessment methodologies, and safety validation techniques. 

• Communication: Excellent communication and documentation skills, with the ability to clearly articulate safety requirements and guidelines. Business level Japanese/English Proficiency is required. 

Preferred Qualifications: 

• Technical Skills: Understanding of automation and robotics safety principles and safety validation techniques. 

• Standards Expertise: Familiarity with ISO 13849, ISO 3691-4, or equivalent JP/EU/US standards. 

• Project Management: Experience in project management, particularly in safety-critical projects. 

• Certifications: Safety certification (e.g., Functional Safety Engineer) or equivalent is a plus. 

• Industry Experience: Experience in safety management within the material handling or autonomous vehicles industry is preferred. 

• Competitive salary 

• Working with exceptionally talented and diverse team 

• Bleeding edge technology 

私たちは、「Empathy（共感）」というコアバリューに基づき、「きつい」「汚い」「危険」な仕事を自動化し、人々がより知的で創造的な仕事にチャレンジできる社会を実現したいと考えています。世界でも最先端の制御技術および人工知能技術を活用した、ロボティクスプラットフォームやロボットソリューションの開発と、企業への導入・運用支援を行うことで、この社会の実現を目指しています。 

これまでの資金調達額は100億円以上にのぼり、毎年右肩上がりの成長を続けています。30ヶ国以上から200名以上の多国籍メンバーが集まり、日本・インド・アメリカを拠点に事業を展開しています。 

現在弊社では、ロボティクス革命のさらなる推進に向けて、熱い志と豊かな才能を持った仲間を募集しています。 

【職務内容】 

 私たちのチームでは、厳しい倉庫環境下で複数のロボットを使用する複雑なプロセスを実行しながら、最大限の安全性を提供する自動フォークリフトソリューション（AFL）の安全性ライフサイクルを定義および管理できるセーフティコンプライアンスマネージャーを募集しています。このポジションの使命は、倉庫内のプロセスを一貫してサポートする、安全でスケーラブルなAFLソリューションを構築することです。 

• 安全ライフサイクル管理: 自動運転フォークリフトの安全ライフサイクルを主導、管理、更新し、安全目標設定、安全要件、リスク評価、安全性の検証、および安全監査を実施する 

• 規格準拠: ISO 12100や同等のJISD規格などの関連する安全規格への準拠を確保する 

• リスク評価: 潜在的なリスクを特定し、適切な安全対策を実施するための徹底的なリスク評価を行う 

• 安全性検証: 全ての安全関連機能が十分にテストおよび検証されるように、安全性検証プロトコルを開発および実行する 

• 文書化および報告: 安全性ケースレポート、コンプライアンス文書、リスク評価記録など、内部および外部の関係者向けに詳細な文書およびレポートを作成する 

• 部門横断的なコラボレーション: 製品開発、品質保証、展開チームと密接に連携し、製品設計、開発、展開プロセスにおける安全性の統合と更新を行う 

• 監査: 安全基準および規制への継続的な準拠を確保するために、定期的な安全監査と検査を実施する 

• トレーニングと開発: 組織内で安全文化を促進するために、エンジニアリングおよび開発チームに対して安全トレーニングと指導を提供する 

【求める人材像】 

必須要件 

• 経験: 自動化、メカトロニクス、ロボティクス、または関連分野での製品開発および安全ライフサイクル管理における3～5年の経験 

• オーナーシップ: 最小限の監督で、問題の定義から実施まで、安全管理の成果に対する強い責任感を持つこと 

• 細部への注意: 安全評価および文書化において高いレベルの正確さと注意を保ちながら、包括性を確保する能力 

• 規格の知識: ISO 12100や同等のJISD規格などの安全規格に精通していること 

• 技術スキル: 安全原則、リスク評価手法、安全性検証技術に関する強い理解 

• コミュニケーション: 安全要件やガイドラインを明確に伝えることができる優れたコミュニケーションスキルおよび文書作成スキル

• ビジネスレベルの英語 / 日本語能力 
  

望ましい要件 

• 技術スキル: 自動化およびロボティクスの安全原則と安全性検証技術の理解 

• 規格の専門知識: ISO 13849、ISO 3691-4、または同等のJP/EU/US規格に精通していること 

• プロジェクト管理: 特に安全クリティカルなプロジェクトにおけるプロジェクト管理の経験 

• 認証: 安全認証（例：機能安全エンジニア）または同等の資格があれば尚良し 

• 業界経験: 材料ハンドリングまたは自動運転車両業界での安全管理経験が望ましい 

Product Compliance & Risk Manager - Japan

We’re looking for a Product Compliance & Risk Manager to join our growing Product Compliance team in APAC and to help out the Japan team. This role is hands-on, a unique opportunity to have an impact on Wise’s mission and help save millions more people money. You will either be based in Japan / Singapore. 

Your mission: 

Wise has already pioneered new ways for people to transfer money across borders and currencies. Your mission is to work with our product teams to launch new products and grow our presence in Japan through a deep understanding of the regulatory requirements and Regulators’ expectations around them. 

This is a first line Product Compliance role, embedded in the APAC Product Squad. You, together with the team in Japan, will be responsible for:  

Creating and improving our amazing products: 

• Deeply understand regulatory needs, translate this into solutions and work together with the Product Teams to build compliant new products and services  in a customer oriented way; 
• Perform regulatory analysis of new products and services, and ensure that related controls are implemented consistently prior to launch. 

Regulatory risk and remediation:  

• By understanding both the Wise product deeply enough and the local regulatory expectations - support Product and other teams on how to interpret regulatory requirements, improve processes and our product to avoid regulatory breaches and/or incidents; 
• In collaboration with second line Compliance and Risk teams, identify and align on the main regulatory issues and risks in Japan. Present this in a very clear and understandable way to the wider teams, to work with them on defining the solutions and how this should be executed. 

This role will give you the opportunity to: 

• Grow your hands-on Fintech knowledge at full speed; 
• Build best-in-class products: The role is a unique opportunity to build state-of-the-art products that are compliant for our customers and regulators;
• Work together with all our amazing teams both locally and globally 

1. The Senior Manager, Quality Operational Capabilities is responsible for managing local SOP, TMF plan, relevant systems/process for clinical operation, Quality oversight of clinical trial, supporting for planning and conducting global annual audit plans, and all activities to maximize clinical operation capability across studies for Japan.

2. He/She collaborate with multiple functions in global clinical operation(GCO) and R&D Quality & Compliance(RDQC) to be consistent with global process and also work within and outside R&D such as global/local finance or sourcing team.

3. He/She serves as the leader of the Japanese inspection response team responsible for preparing for and responding to inspection conducted by PMDA. Also he/she acts as the primary point of contact for the global inspection team and regulatory authorities, leading the coordination of inspection responses.

4. As part of vendor management responsibilities, he/she collaborates with stakeholders both within and outside the R&D department, such as Japan Study Lead(JSL), Clinical Financial Planner(CFP), Global/Local finance, and sourcing teams, to be responsible for budget management and contract management processes of local CROs and vendors.

5. He/She will demonstrate leadership in the clinical support team and will be tasked with supporting peers and managing several staffs.

Local SOP、TMF計画、臨床オペレーション業務に関連するシステム、臨床試験の品質管理、査察準備を含む日本での試験全体の臨床オペレーション業務遂行能力を最大化するための業務を管理する責任を負う。

Globalのプロセスと一貫性を保つため、Global Clinical Operation（GCO）の複数の部門と協力し、またGlobal/Localの財務やソーシングチームなど、R&Dの内外のステークホルダーと業務を行う。

必要に応じて、バイオジェンジャパンが単独で臨床試験を実施する場合や、ローカルCROに外部委託する場合には、GlobalのメインCROに準じた業務手順や体制の設定を調整する。

クリニカルサポートチームでリーダーシップを発揮し、同僚のサポートや複数のスタッフの管理を行う。

Position Overview

You will report directly to the Senior Director, License Compliance in a hybrid position. You will lead a team in License Compliance Sales to develop strategies to ensure the revenue generation of Autodesk's License Compliance software program. You will research and identify customers out of compliance. You will promote and initiate our creative program strategies, collaborate, ensure and influence channel support of the programs. Establish and implement guidelines to ensure consistencies while creating and modifying strategy to meet the needs of our customers in different countries.

Responsibilities

• You will manage a team of our accomplished License compliance sales professionals to exceed assigned quotas, ensuring team efficiency and revenue goals are met
• You will lead the way in working collaboratively with our Territory sales teams on account planning activities to ensure the best customer experiences
• Manage sales Indicators, pipeline and activity metrics (all leading indicators) of team to ensure these are tracking towards achievement of revenue goals.
• Deliver timely and accurate forecasting of the business, and pipeline management
• Track metrics and ensures balance of sales end enforcement activity is maintained
• Responsible for hiring, team effectiveness, performance management and skill development of staff
• Monitor and reviews long-term goals of the program and ensure our campaigns are performed within budget and that License Compliance revenue targets are met
• Collaborate on best practices and lead License Compliance strategies with other geographies
• May engage in final stage negotiation with C level customers
• May make presentations to customers about the benefits of Autodesk software
• Be the first point of escalation when a customer case is stuck or not moving in the right direction

Minimum Qualifications

• 10+ years of relevant experience
• Sales experience and track record working with large-scale customers handling main accounts in an enterprise segment
• Sales experience exceeding quotas
• Experience digging into prospects' pain points and validating the issues they're facing experience with C level customers
• Experience or knowledge in Cyber security industry is a benefit
• Experience selling in value-based selling models a benefit
• Experience in negotiation and conflict resolution
• Experience engaging with senior executive levels

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Learn More

About Autodesk
Welcome to Autodesk! Amazing things are created every day with our software – from the greenest buildings and cleanest cars to the smartest factories and biggest hit movies. We help innovators turn their ideas into reality, transforming not only how things are made, but what can be made.

We take great pride in our culture here at Autodesk – our Culture Code is at the core of everything we do. Our values and ways of working help our people thrive and realize their potential, which leads to even better outcomes for our customers.

When you’re an Autodesker, you can be your whole, authentic self and do meaningful work that helps build a better future for all. Ready to shape the world and your future? Join us!

Salary transparency

Sales Careers

Working in sales at Autodesk allows you to build meaningful relationships with customers while growing your career. Join us and help make a better, more sustainable world. Learn more here: https://www.autodesk.com/careers/sales

Diversity & Belonging
We take pride in cultivating a culture of belonging and an equitable workplace where everyone can thrive. Learn more here: https://www.autodesk.com/company/diversity-and-belonging

Are you an existing contractor or consultant with Autodesk?

Please search for open jobs and apply internally (not on this external site).

Responsibilities 

The successful applicant will possess strong knowledge of the rules and regulations applicable to the Japanese financial industry, experience with dealing with Japanese financial regulators such as the JFSA, KFB, SESC and JSDA and good client facing skills.

Tasks

• Assist with providing ongoing regulatory compliance support to our client base in Japan.
• Handl regular compliance meetings with clients and deliver compliance reports to clients in a timely manner.
• Maintain client records in the system in a timely manner.
• Handle client compliance enquiries and provide responses in a timely manner.
• Draft compliance manuals, policies and procedures.
• Review regulatory returns and forms and compliance checklists prepared by junior staff.
• Be a subject matter expert and main point of contact to clients, providing support and guidance on Japanese regulatory compliance matters.
• Training of new joiners and technical training to other colleagues on Japanese regulatory compliance issues.
• Implementing and driving efficiency within the team, supervising tasks performed by team members.
• Perform any ad hoc tasks as instructed by the Managing Director as required.

Job Title

Job Description

仕事内容:

当社が取り扱う一般家庭用の家電製品について、製品導入や製品管理に携わるポジションです。

■業務概要

・マーケティングプランに沿った新製品導入、および、製品ライフサイクルマネジメントのプロジェクト管理

・グローバルコンテンツのローカライゼーション(取扱説明書、製品箱、等)

・ローカルコンテンツの作成とサポート(仕様書、検査指示書、等)

・製品仕様確認

・製品の4M/仕様変更に付随する調整と対応

・製品問い合わせ対応と技術サポート

■応募資格

【必須（MUST）】

・目の前の情報を容易には信じず、正しいと判断するために自ら情報を集める力

・基本的なWord、Excel、PowerPointの取り扱いができる方

・他者と円滑にコミュニケーションを取れる方

・英語でのコミュニケーションに抵抗がない方

※日常的に海外とメールや電話会議でのコミュニケーションがあります

・向上心が高く、自ら学ぶ姿勢がある方。業界未経験も歓迎します。

・プロジェクト管理経験

【歓迎（WANT）】

・電気系、若しくは工学系のバックグラウンドのある方

・製造事業者、若しくは輸入事業者で製品導入に携わった経験のある方（業界は問いません）

・家電に関連する法規の知識を有する方（電安法、消安法、電波法、景表法、等）

【その他】

契約期間            期間の定めなし

試用期間            試用期間あり(原則として入社日より6ヶ月)

就業場所            東京

就業時間            9:00-17:30 休憩時間: 原則として12:00-13:00

休日                    毎週土(所定休日)、日曜日(法定休日)、国民の祝日、年末年始(12月29日-1月4日)

休暇                    有給休暇:初年度最大20日間(入社月により変動します)、Care Leave(年間10日間付与)、Sick Leaveほか

時間外労働       あり みなし勤務時間制(事業場外労働制)

給与                    経験を考慮して優遇します

賞与                    あり

※インセンティブは四半期ごとに支給(会社業績、部門業績、個人評価によって変動あり)

※年度途中入社者は対象期間中日割計算あり

加入保険            社会保険(厚生年金保険、健康保険)・労働保険(雇用保険、労災保険)

所属社名            株式会社フィリップス・ジャパン

【会社概要】

フィリップスは、「2030年までに年間30億人の生活を向上させる」ことをミッションに掲げ、ヘルスケアカンパニーとして世界中で培った技術と知見を生かしながら、健康な生活、予防、診断、治療、ホームケアという「一連のヘルスケアプロセス」においてイノベーションを実現してまいりました。今後も、超高齢社会における日本の医療と健康問題に一層向き合い、社会への貢献を果たしていくためにも、ヘルステックカンパニーとして生まれ変わり、デジタル化を加速してまいります。

フィリップスのデジタル・プラットフォームにおいてプロフェッショナル・ヘルスケア(病院の医療)とパーソナル・ヘルスケア(ホームケア)をつなぐことにより、地域社会の医療の充実や患者様の負担軽減、健康社会の実現に向け、有意義なソリューションを提供していくとともに、あらゆる医療関係機関や他業種の方々とのエコシステムにより、「フィリップス・ジャパン」として、未来に向け新しい企業価値を創造してまいります。

Career Category

Job Description

Live

What you will do

Responsibilities include, but not limited to:

• Creates QMS and GQP operating procedures per the Pharmaceutical Medical Devise Affairs Law - products may include sterile injectable monoclonal antibodies and proteins in vials, syringes and devices; and small molecules in solid oral dosage form
• Contributes to the Amgen KK(AKK) and Export countries’ mission, vision and strategy by performing disposition, quality management and oversight on CMOs.
• Leading projects such as tech transfer for export products to CMO as a Quality.
• Contributes to Quality deliverables for Japan and/or Export countries product launches, lifecycle events and other commercialization activities
• Manage GxP system (CAPA, Change Control, Deviation, Self-inspection, Training, Complaint, Recall, etc.)
• Supports Authority Inspections with Amgen and AKK colleagues
• Quality oversight of Contract Manufactures mainly, and Contract Laboratories and Logistic Service Providers as needed
• Contributes implementation of Quality Management System and Standard Procedures per ICH Q10 and PAL; to include Information Systems and GMP Procedures
• Supports Audit program management for key Japanese suppliers to Amgen. These suppliers may include contract manufacturers mainly,    and  contract laboratories, final packaging materials suppliers and service providers as needed.
• Contributes the GMP Intelligence Program to assess and monitor Japanese and export countries’ regulations, standards and guidance documents related to GxP, product testing and Japanese and/or export countries’ Pharmacopoeia requirements

Win

What we expect of you

Basic Qualifications

• Doctorate +2, Masters +4, Bachelors +5 years of directly related experience in quality assurance and quality related activities.
• Demonstrated ability to manage relationship development and maintenance and negotiation skills.
• Experience performing GMP audits of laboratories that perform analytical testing of biologics, LSPs and packaging suppliers.
• Pharmaceutical/ Biologics product commercialization and lifecycle management experience
• Knowledge of regulatory authority inspection processes
• Experience in Japan with multiple language capability (English, Japanese)
• Strong verbal and written communications skills. Must be able to effectively articulate ideas with same levels of an organization.
• Self leadership and motivation with high personal integrity and application of Amgen Values in daily operations.
• Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a  team of seconded staff
• Ability for travel to international destinations as needed

Preferred Qualifications

• Leadership experience leading teams, projects, programs or directing the allocation of resources
• Experience with Japanese pharmaceutical companies
• Experience working with biologics (monoclonal antibodies and/or proteins) and small molecule solid oral dosage forms in Japan
• Experience with commercial products
• Experience with medical devices in Japan

Quality Assurance and Safety Management

• Collaborate with related functions and be responsible for maintaining and configuring QMS and ISO13485 in accordance with change control processes.
• Lead the company's compliance activities according to PMD Act/ISO13485/15189 and applicable requirements.
• Maintain both QMS and GVP under MAH, including Shonan laboratory.
• Conduct internal audits and top management reviews based on the regulations.
• Communication with the regulatory authorities and notified bodies regarding safety information.
• Collect and manage safety information and lead necessary action.
• Report and respond to related regulatory authorities.
• Ensure that all SOPs are written following applicable regulatory and company requirements.

Regulatory Affairs

1. Responsible for activities that lead and maintain regulatory promotion code for In Vitro Diagnostic (IVD) devices, medical devices, and RUO products.
2. Support to create and review a submission package and product insert.
3. Lead QMS assessment regarding submission of new products to PMDA
4. Maintain and manage FMR with collaborating GHI.
5. Lead the company's compliance activities according to the PMD Act/Promotion guideline/ Fair Competition Code and applicable requirements.
6. Maintain and change control MAH and IVD sales license.