Quality Assurance Leader (RE-33912557)

Location: Tokyo, Japan
Salary: ¥8000000 - ¥10000000 per annum + competitive
Job Type: Permanent
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<About the position>

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products meet specified standards.

The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations with regards to the area of responsibility and specialization in support of continuous business and organizational growth.

<About the company>

A leading global innovator at Medical Devices, Image Diagnostics, and digital solutions that continues to improve the workflow of medical professionals by developing best class Medical Devices and Pharmaceutical products, while delivering data analytics services and applications

<Responsibilities>

  • Own the QA process under, e.g., Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, etc.
  • Function as Hinseki to support the Sanyaku organization within the Japan office
  • Lead the preparation and execution of Quality Management Reviews for the region
  • Manage quality evaluation of warehouse operations, manufacturing sites, and external laboratories
  • Provide support to routine activities, projects, development and training relevant to area of expertise where required
  • Support continuous improvement activities regarding areas of responsibility
  • Engaging assessment regulatory impact on product and manufacturing processes.
  • Engaging site inspections, preparing audits observations response as necessary
  • Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters

<Required Qualifications>

  • B.S. Degree in bioscience, chemistry, pharmaceutical, business or technical field
  • 7 years of QA experience in Pharma/Medical device or other regulated industry in total, at least 3-5 years of QA experience in a pharmaceutical and/or medical device manufacturing environment
  • Proficient with MS software
  • Proficient with eQMS and eDMS systems
  • Ability to work independently in a fast-paced team environment with little supervision
  • Ability to communicate effectively in Japanese and basic level of English
  • Strong managerial, people guidance, project management and time-management skills

<Desired Characteristics>

  • Strong oral and written communication skills. Strong interpersonal and leadership skills. Established project management skills
  • Pharmacist license
  • Experience being in Sokatsu and Hinseki roles
  • Working experience in MNC pharmaceutical/medical device/healthcare product organizations
  • Experiences with CAPA systems and experiences applying regulations (GMP, Good Distribution Practices)
  • QC testing experience for sterile products

Real is part of the larger SThree K.K group

To find out more about Real, please visit www.realstaffing.com | Real についてもっと詳しく知りたい方はこちらへ→ www.realstaffing.com

Award winner of:

Great Place to Work 2019 | Growth Company of the Year by TALint Recruitment Awards 2019 | Best Healthcare & Life Sciences Recruitment Company of the Year by Recruitment International Awards 2018

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