66 QA Engineering Jobs in Tokyo, Japan

Role highlights

• [Required] 5+ years of experience in Quality Assurance, Quality Control, Production Engineering, Technical Support, Customer Support, or re…
• Quality Engineer for Japan, you will own market quality activities across the product lifecycle and serve as a key bridge…

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• Provide hands-on guidance and initiate improvement activities to enhance product quality, compliance, and customer satisfaction by working…
• Quality Engineer I Reporting To: Entity GM - Japan Work Schedule: Hybrid – Hiratsuka, JP Main Responsibilities: Responsible for Senior…

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• Key Activities & Accountabilities Responsibilities of this job is the appropriate execution of approval applications/notifications for medi…
• The duties are as follows: Manufacturing and distribution/certification approval, notifications (including planning, collecting data, and P…

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• Compliance Oversee Quality Management System (QMS) activities and Manufacturing control activities under the direction of Domestic Quality…
• Continuous Improvement Supports cross-functional improvement initiatives Process improvements for QMS effectiveness and PMD Act compliance,…

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• Capability in office work and project management.
• Identify new research opportunities and provide support for Investigator Sponsored Studies (ISS) and Amgen Sponsored Trials as necessary.

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• Objective / Purpose: This position is responsible for GMP manufacturing of biologics drug substances (DS) and sterile drug products (DP)…
• To carry out facility maintenance, GMP manufacturing, testing operations and manufacturing technology development Establish and maintain sa…

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• This experienced scientist leads process chemistry activities for synthetic small molecule early-stage development (i.e. pre-clinical stage…
• This role designs phase-appropriate and scalable synthetic processes, oversees development and manufacturing activities including CDMO coll…

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• In regulatory affairs, as a regulatory expert, we participate in pharmaceutical project teams to provide advice and support to the…
• Ensure maintenance and compliance of regulatory activities for development and marketed products.

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• Leadership & Management: Recruit, hire, and develop a high-performing team of RA/QA/Safety Control professionals.
• Collaborate effectively with internal and external stakeholders, including ISJ, APAC RAQA, Global RAQA, Marketing, SCM, R&D and manufacturi…

Role highlights

• Required Skills: Preferred Skills: Agile Manufacturing, Analytical Reasoning, Brand Research, Coaching, Detail-Oriented, Developing Others,…
• EHSS（環境安全衛生）スタンダードを元に安全に作業できる環境を実現する 職務及び責務 目標に基づき、グループの方針・目標を設定し 、部門目標の達成を図る 設備・機構デザイン 1）電気、機械機構 、周辺デザインのサポート、提案 2）電気、機械の安全機構のデザインサポート、指示…

Role highlights

• Experience in downstream process development for biologics, including chromatography, filtration, process characterization, scale-up, and t…
• How you will contribute: Provide scientific and technical expertise in the downstream process development activities across biologics progr…

Role highlights

• You will apply deep product development expertise to lead ideas from concept to execution, contributing to a strong and diverse…
• Working closely with scientists/ managers and cross-functional partners, you will conduct laboratory experiments, prepare prototypes, colle…

Role highlights

• 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、A…
• We would prefer for you to have: Bachelor’s degree plus more than 5 years-experience in pharma or bio industry CMC…

Role highlights

• Required Skills: Preferred Skills: Analytical Reasoning, Analytics Insights, Coaching, Collaboration, Data Analysis, Data Savvy, Detail-Ori…
• Ü Lead discussions and implement solutions for operational issues in collaboration with HCC, Legal, Finance, and iMA stakeholders.

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• Responsibilities may include assisting with or primary responsibility for: Site Selection Pre-trial assessment Site level Study Participant…
• Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.

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• This role requires strong pharmacovigilance knowledge, attention to detail, and the ability to work effectively in a fast-paced, client-foc…
• Key Responsibilities Safety Case Processing & Assessment Receive and review safety case reports from multiple sources, including healthcare…

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• Learn about the Danaher Business System which makes everything possible The Specialist, Commercial RAQA is responsible for serving as the…
• This position reports to DHR Dx Commercial QARA manager and Radiometer Japan General Manager and is part of the QARA…

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• Participate in cross-functional team for new product introduction to provide expertise in quality and safety of Medical Devices, IVDs, and…
• Organize and review processes, Quality Manual, Standard Operation Procedures, Working Instructions, QMS records, and other documents to ass…

Role highlights

• MAJOR RESPONSIBILITIES Strategic support Understand regional specificities and regulations, get local alignment, and provide one "Country v…
• Technical Expertise Provide reliable technical advice and expertise to the country teams: support business case evaluation, contribute to t…

Role highlights

• POSITION SUMMARY The Senior Process Engineer (MSAT) serves as a subject matter expert in large-scale bioprocessing and biomanufacturing, wi…
• KEY RESPONSIBILITIES Technical Expertise & Process Support Serve as a recognized expert in large-scale bioprocessing, with a focus on TFF,…

Role highlights

• Others: Lead, coach, develop, and motivate Regulatory Affairs, Quality, and Vigilance team members.
• Experience developing regulatory strategies, managing product registrations, and supporting lifecycle management activities within the medi…

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• Prepare regulatory submission materials and support communication with health authorities in coordination with internal functions.
• Key Activities Perform MAH-related tasks: preparation and documentation for the Three Supervisors’ Committee, SOP/document management, insp…

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• Guide or train cross-functional team members on Medical Writing processes and standards.
• Required Skills: Preferred Skills: Analytics Insights, Business Writing, Clinical Research and Regulations, Clinical Trials Operations, Cop…

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• We are seeking an experienced Senior Quality Assurance Manager to lead and maintain our local Quality Management System, ensuring complianc…
• This role is responsible for driving quality excellence across the affiliate, providing strategic quality leadership, supporting product li…

Role highlights

• Oversee the full PMS lifecycle — guide the team through study outline development, protocol and case report form creation, global…
• Champion cross-functional collaboration — build and sustain strong partnerships with Development, Medical, Safety, Regulatory Affairs, and…