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
Yokohama Kanagawa Japan

Salary Criteria