21 Quality Engineering jobs in Tokyo.

Hiring now: Safety Mgr Japan @ Biomarin P, Mgr Quality Assurance Dis @ Regeneron, Lead Spec Regulatory Affa @ Stryker, Sr Mgr Cmc Regulatory Aff @ Regeneron , Hardware Quality Assuranc @ Rakuten Mo, Technical Consultant @ Veeva Syst, Sr Specmgr Regulatory Aff @ Bd, シニアCqvエンジニア Sr Cqv Engr @ Cai, Head Regulatory Writing @ Novartis, Contract Manufacturing Sp @ Amgen.Explore more at jobswithgpt.com.

🔥 Skills

project management (5) pharmacovigilance (4) compliance (4) training (4) adverse events (3) GVP (3) medical devices (3) Compliance (3) SOPs (2) audit (2)

📍 Locations

Tokyo (21)
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Biomarin Pharmaceutical Inc.

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, adverse events, GVP, compliance, training, regulatory reporting, SOPs, local health authority, audit, safety database
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.

Regeneron

Manager, Quality Assurance & Distribution Tokyo
Skills & Focus: Quality Assurance, GQP, GMP, Pharmaceutical Industry, Quality Management, Deviation, Inspection, Document Control, Quality Improvement, Training
Experience: At least 7 year experience in pharmaceutical industry GMP/GQP as a QA Manager
Type: Contract
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Stryker

Lead Specialist, Regulatory Affairs Tokyo
Skills & Focus: Regulatory Affairs, approval applications, medical devices, PMDA consultations, QMS compliance, certification, communication, project management, healthcare outcomes, medical insurance
About the Company: Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its c…
Experience: 3+ years of experience of medical device (Class I to IV) application approvals
Type: Full Time
Benefits: Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness …

Regeneron Pharmaceuticals Inc.

Senior Manager, CMC Regulatory Affairs Tokyo
Skills & Focus: CMC, regulatory affairs, Oncology, Hematology, NDA, PCA, MCN, PMDA, biopharmaceuticals, biologics
Experience: over 10 years
Benefits: health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off

Rakuten Mobile

Hardware Quality Assurance Lead Tokyo
Skills & Focus: Hardware Quality Assurance, Specification Conformance, Structural Confirmation, Product Verification, Pre-Delivery Inspection, Documentation Management, Risk Assessments, Manufacturing Quality, Quality Control, Factory Audits
About the Company: At Rakuten Mobile, we engage in verification and quality assurance activities for the products we handle, encompassing hardware and software safety, reliabilit…
Experience: Experience in consumer product development and hardware verification; practical experience in auditing production lines and conducting acceptance inspections.

Veeva Systems

Technical Consultant Tokyo
Skills & Focus: Technical Consultant, RTSM, Randomization, Trial Supply Management, cloud-based solutions, custom code, life sciences, expedite trials, treatments, customers
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster.

Bd

Senior Specialist/Manager Regulatory Affairs Tokyo
Skills & Focus: regulatory affairs, FDA, medical devices, compliance, pharmaceutical, product registration, Good Clinical Practices, project management, communication skills, organizational skills
About the Company: BD is one of the largest global medical technology companies in the world, improving medical discovery, diagnostics and the delivery of care.
Experience: Minimum of five years of experience in pharmaceutical industry
Salary: Competitive
Type: Full-Time
Benefits: Healthcare, 401(k)/Retirement Plans, Employer Matching, Tuition Reimbursement, Paid Time Off

Cai

シニアCQVエンジニア (Senior CQV Engineer) Tokyo
Skills & Focus: Commissioning, Qualification, Validation, CQV documentation, FDA regulated, Project management, Technical problem-solving, Aseptic processing, Biotechnology, Microsoft Word and Excel proficiency
About the Company: CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualificat…
Experience: 5 – 12 years in commissioning and/or qualification activities in an FDA regulated industry
Salary: 年収800万円〜1,000万円 (Approximately 800,000 to 1,000,000 JPY)
Type: 正社員 (Full-time)
Benefits: Competitive Salary, Continuing education (internal and external), Opportunities to work on cutting edge projects in a h…

Novartis

Head Regulatory Writing Tokyo
Skills & Focus: regulatory writing, clinical documentation, business management, quality control, clinical study reports, technical documents, coaching, mentoring, auditing, compliance
About the Company: Novartis is an innovative medicines company, working to reimagine medicine to improve and extend people’s lives. Our medicines reach more than 250 million peop…

Biomarin Pharmaceutical Inc.

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, GVP, regulatory compliance, adverse events, safety information, SOPs, local regulations, training, audit, collaboration
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.

Amgen

Contract Manufacturing Specialist Tokyo
Skills & Focus: contract manufacturing, cGMP, project management, data analysis, collaborative leadership, regulatory guidelines, continuous improvement, technical writing, problem-solving, influencing skills
About the Company: Amgen is one of the world's leading biotechnology companies dedicated to serving patients and developing treatments.
Experience: 5 years of contract manufacturing management experience
Type: Full-time
Benefits: Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits.

Biogen

Manager, Clinical Quality Management Tokyo
Skills & Focus: Clinical Quality Management, SOP, TMF, Clinical Operations, Quality Oversight, Global Audit, Inspection Response, Vendor Management, Budget Management, Contract Management

Intuitive Surgical

Quality Assurance Specialist (Product Quality) Tokyo
Skills & Focus: Quality Assurance, Quality Control, Quality Management System, Risk Management, Customer Complaints, Regulatory Agencies, Field Action, Data Analysis, CAPA, Project Management
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: Minimum 3 years experience in Pharmaceutical/Medical Device/IVD industries or Minimum 3 years experience related to Quality in any manufacturing industries

Biogen

Manager, Drug Safety Tokyo
Skills & Focus: Drug Safety, Pharmacovigilance, Regulations, Clinical Trials, Signal Management, Compliance, Quality Management System, Process Improvement, Vendor Management, NDA

Amgen

Post Marketing Surveillance (PMS) Sr Associate Tokyo
Skills & Focus: Post Marketing Surveillance, project management, PMS activities, regulatory compliance, data management, process improvement, budget management, collaboration, quality assurance, training
Type: Full time
QA Manager (External sites management) Tokyo
Skills & Focus: Quality, Compliance, GMP, Audits, Pharmaceutical, Biologics, Regulatory, Manufacturing, Inspection readiness, Risk management
Experience: Doctorate degree & 2 years of directly related experience OR Master’s degree & 4 years of directly related experience OR Bachelor’s degree & 5 years of directly related experience
Type: Full time

Biomarin

Safety Manager - Japan Tokyo
Skills & Focus: pharmacovigilance, safety, regulatory, compliance, adverse events, training, monitoring, audits, GVP, document review
Experience: Minimum of 5 years previous pharmacovigilance experience in Japan as a manager position.
Type: Hybrid

Astrazeneca

Director, Global Regulatory Affairs CMC Japan Tokyo
Skills & Focus: Global Regulatory, Chemistry, Manufacturing, Controls, GRA-CMC, Regulatory Strategy, Submissions, Compliance, Biopharmaceutical, Product Lifecycle
About the Company: AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines.
Experience: At least 8 years of GRA-CMC experience

Rakuten Mobile

After-Sales Service Quality Control Specialist Tokyo
Skills & Focus: After-sales service, product quality control, terminal defects, technical support, market quality control, consumer products, operations experience, quality control work, stakeholders, customer support
About the Company: In Product handled by Rakuten Mobile, we will be responsible for product quality responsibility from the release to the end of maintenance.
Experience: Construction of consumer products after sales service, operations experience; Quality control work experience of consumer products

Cai

Senior CQV Project Manager Tokyo
Skills & Focus: CQV, commissioning, qualification, validation, project management, FDA regulations, pharmaceutical, medical devices, troubleshooting, biotechnology
About the Company: CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualificat…
Experience: 15+ years in commissioning, qualification, and validation in FDA-regulated industries
Salary: Salary will be determined in accordance with the Company's regulations after due consideration of experience, ability, and other factors.
Type: Full-time
Benefits: Competitive salary, ongoing education (internal and external), opportunity to work on cutting-edge projects in a rapidl…

Ergomed

Senior PV Officer Tokyo
Skills & Focus: pharmacovigilance, case processing, Individual Case Safety Reports, SAE/SUSAR submissions, regulatory requirements, PBRER, DSUR, PADER, mentoring, continuous improvement