Quality Assurance Manager

勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
給料 Negotiatable
参照番号 36986


A global biotechnology company



This position will directly report to Quality Assurance supervisor Japan and have responsibility for leading the execution of all Quality Assurance (GQP/QMS) activities.

  • Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives

  • from Medical device and drug perspective.

  • Contribute to Product life cycle management in a global organization, among

  • global/domestic companies (change management, quality agreement, audit, quality issue handling, CAPA etc.)

  • Ensure full compliance with applicable regulations in Japan.

  • Oversee all activities or responsibilities that are delegated to external parties.



  • 5+ years Knowledge of relevant in Quality Assurance in healthcare (pharmaceutical or medical devices) industry.

  • Experience quality operations listed below in post-marketing and/or manufacturing environment.

  • Quality information handling such as complaint, deviation, CAPA etc

  • Improvement of quality processes as shown the above

  • Establish, revise or maintain SOPs

  • Auditing suppliers

  • Inspection by authorities

  • Understanding of PMD Act, relevant regulations and guidelines.

  • Experience communication in English with business partners, ability to communicate reading, writing, and speaking in English is strongly preferred.

  • Bachelor's Degree in Science or related discipline