JOB INFORMATION
求人情報

求人番号 76305-069

製薬・医療機器業界

外資系 メディカル

品質保証部 ディレクター

  • 年収
    非公開
  • 勤務地
    東京都
  • 英語力
    上級

外資系製薬企業の品質保証ディレクターのポジションです。

職務内容
・Responsible for quality oversight and regulatory compliance of products marketed in the country, including product release and Quality aspects of the product life cycle management.
・Responsible for quality approval and management of local 3rd party service providers/suppliers/manufacturers/distributers.
・To overview, support and provide guidance for manufacturing plants, local and overseas, so that they can perform appropriate manufacturing and quality control, in accordance to the current GQP Ministerial Ordinance
・To establish and maintain Quality procedures, in accordance with Mylan’s Quality Policies and SOPs, as well as with Local Requirements, to ensure the Quality, Safety and Compliance of Mylan’s products and services.
・To analyze and provide disposition on Quality processes (not limited to): Changes impacting GxPs, Quality Deviations, Quality parts of Regulatory submissions, Customer Complaints, Quality Technical Agreements, Field Actions, Supplier Qualification and Approval
・To provide support and/or be part of Mylan’s “Sanyaku”.
・To represent Quality Division in internal/external meetings and committees, including Quality related projects and associations.
・To appropriately perform talent management in order to hire manage and retain talents within the department.
応募条件
経験・スキル 必須要件
・10 years’comprehensive Quality experience with pharmaceutical companies
・Deep knowledge of ICH, GQP/GMP regulations
望ましい要件
・Pharmacist
・Experience as Sokatsu and/or Hinseki
・R&D experiences in CM&C area.
・Working experiences in manufacturing or laboratory

資格・ライセンス
・Managerial experience including team-building and human resources development
・Strong leadership, communication, creative and analytical skills
・Mentor and coach team members as the team leader, reviewing their progress and field reports
・Strong communication and presentation skills; able to interface at all stakeholder levels
・Negotiation skill with business related authorities, business partner and supplier.
・英語力 Business Level (TOEIC800)
無料オンライン登録

厳選求人詳細

  • 外資系 メディカル

    PMSモニター

    ・製造販売後調査実施における施設対応 ・医療機関への調査説明及び依頼 ・契約手続...

    この求人の詳細を見る
  • 外資系 メディカル

    Product Manager(クリアレンズ)

    - マーケティング部に所属し、クリアレンズをご担当いただきます - 日本法人では...

    この求人の詳細を見る
  • 外資系 メディカル

    Commercial Regulatory Assurance Manager

    Manager of Commercial RA will lead the R...

    この求人の詳細を見る
  • 無料登録

求人検索

  • 管理部門の転職情報
  • ISSコンサルティング採用情報
  • オンライン登録

転職のご相談、求人応募・お問い合わせには、
まず無料登録をお願いします。

無料オンライン登録

SNS

企業インタビューやセミナー
業界転職情報をお届け!

Arrow