QA Manager

Posted 13 May 2022

Yokohama, Kanagawa - Japan

Req Id 244974


A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Your Role: As the Quality Assurance Manager, you are a key business enabler supporting our mission to deliver the highest quality testing services and regulatory expertise that advance life-changing medicines to patients.


Key Responsibilities

  • Maintains QMS in conformance with ISO 9001 requirements
  • Hosts and conduct audits
  • Performs timely reviews of test protocols and reports
  • Leads root cause investigations and develops CAPAs
  • Proactively identifies and communicates risks
  • Works with global counterparts to support key strategic projects
  • Models behaviors and values that promote a positive quality culture


Who are you:

Minimum Qualifications

  • Practical knowledge of risk management principles and application of risk-based thinking
  • Strong interpersonal skills and ability to interact with all levels of the organization and cross- culturally
  • Excellent communicator with strong leadership, presentation and influencing skills
  • B.S in scientific or allied health field (or equivalent degree) and 5+years of relevant work experience
  • Business level of English (TOEIC above 700) and near native level Japanese


Preferred Qualifications

  • Expérience using TrackWise for audits, deviation, CAPA and change control
  • Working experience in GMP environment.
  • Practical knowledge of industry standards and best practices in one or more of the following: computer system validation, spreadsheet qualification, development and validation of analytical test methods, data integrity requirements and calibration/metrology fundamentals
  • Lean & Six Sigma training
  • Qualified Auditor
  • Expérience using Fishbone, FMEA, Fault Trees and other problem-solving tools
  • Practical experience with Office 365 applications
  • Experience managing people


Work Environment/Culture:
Office location is Yokohama, Kanagawa
Flexible work style available (Remote work 2~3 days/week)
Open work environment and flat organization.


Recruiting Contact: Maiko Yamasue




What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!


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