エージェント求人

QA Manager (Head)

年収非公開

企業名非公開

東京都中央区

募集要項選考・企業概要

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