Regional Clinical Compliance Lead/品質管理(QC)/品質保証(QA) 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬
最終更新日: 2019年 04月 26日





Regional Clinical Compliance Lead



This role will report to the Head of Regional Clinical Compliance APAC who is a member of the Global Clinical Compliance & Continuous Improvement (GCC&CI;) leadership team under Global Clinical Operations (GCO) based in Japan. This role is also based in Japan.

In partnership with the Regional Clinical Operations and Global Quality,
・Support the regional study teams and sites to assure inspection and audit readiness at all times.
・Lead the implementation of the Quality Audit Plans with on-site support prior to, and during internal audits.
・Coordinate site and sponsor inspections by Health Authorities as necessary.
・ In partnership with the Regional Clinical Operations teams, provide appropriate continued oversight to study teams.
・ Work closely with the Clinical Quality and Risk Management team and help implement elements of the Quality Management System: identify emerging and significant risks, provide support for root cause analyses and mitigation strategies, ensure documentation and appropriately notify/escalate to the right level of Governance.
・Provide CAPA leadership by coordinating CAPA development and approval, as well as implementation and tracking of effectiveness.
・Partner with the Clinical Training, Process and Continuous Improvement organization to identify gaps/needs in training at the regional level, and providing local training support/coordination as needed.
・As the scope of Global Clinical Operations includes registrational and non registrational data generation (NRDG), regional clinical compliance activities will span across Phase I through IV studies including Investigator-Sponsored Research and Real World Data Generation. In that context, partner with GCO NRDG teams to enhance GCP compliance for NRDG in partnership with Regional/Country Medical.
・ Work with management and Global Quality to foster a regional, cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.


  • ・GCP関連の豊富な経験


  • 応相談


  • 正社員


  • 東京


  • 当面なし


  • フレックスタイム制度あり


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