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Online.com
最終更新日: 2018年 09月 19日

求人情報

品質管理(QC)/品質保証(QA)

求人管理No.012880

会社概要

Regional Clinical Compliance Lead

オンサイトサポートで品質監査計画の実施をリード

募集要項

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.

募集条件

  • ・GCP関連の豊富な経験
    ・ビジネスレベルの英語量

勤務開始日

  • 応相談

雇用形態

  • 正社員

勤務地

  • 東京

転勤有無

  • 当面なし

勤務時間

  • フレックスタイム制度あり

給与

  • ご経験に応じての額となります。