RECRUIT DIRECT SCOUT リクルートダイレクトスカウト PRODUCED BY RECRUIT
RECRUIT DIRECT SCOUT リクルートダイレクトスカウト PRODUCED BY RECRUIT
    エージェント求人

QA Manager (Head)

年収非公開

企業名企業名非公開

所在地東京都中央区

職務内容

職種

  • 医薬品品質保証

  • 医療機器品質保証

仕事内容

  • QA/Quality Assurance
  • QMS

▪Maintaining the QIAGEN QMS on site, implementing local solutions where required ▪Maintain local Regulatory Licenses and be point of contact with Regulatory Authorities ▪Assume the duties of Marketing Authorisation Holder/Marketing Director, as described under Japanese Regulations ▪Assume (or manage) the duties of Safety Control Manager, as described under Japanese Regulations ▪Lead and manage the small local QA team ▪Member of QKK leadership team, interacting with and responding to the needs of the General Manager, Supply Chain and Sales/Service managers ▪Host Regulatory/Notified body audits on site ▪Act as subject matter expert/intermediary in communications between Regulatory/Notified bodies and overseas manufacturing sites ▪Work with the Warehouse/3PL team on a daily basis to ensure smooth running of activities (including re-labelling) ▪Contribute to the Global QA team (English Language required) ▪Communicate with Global Functions (eg. Operations) to address and solve local issues

求める能力・経験

  • QA/Quality Assurance
  • QMS

▪7-10 years experience in Quality Affairs, preferably in a regulated IVD/MD company ▪Experience in hosting Competent Authority/Notified Body Audits ▪Experience with dealing with PMDA and other Japanese agencies e.g. Tokyo Metropolitan Govt. ▪Good spoken and written English ability ▪Experience in a line management position

語学

英語で日常会話が可能

勤務条件

雇用形態

給与

年収非公開

勤務時間

休日・休暇

内訳:完全週休2日制、土曜 日曜 祝日

社会保険

備考

勤務地

配属先

転勤

Tokyo

住所

東京都中央区

制度・福利厚生

制度

リモートワーク可

その他

制度備考

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