Clinical Quality Management Associate Director @ Top Biopharma | マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.の求人詳細

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更新日 2025-05-02
掲載開始日 2025-05-02

Clinical Quality Management Associate Director @ Top Biopharma

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この求人の取扱い会社	マイケル・ペイジ・インターナショナル・ジャパン株式会社/Michael Page International Japan K.K.
企業名	会社名非公開
職種	メディカル/医薬/バイオ/素材/食品 - 品質管理/保証メディカル/医薬/バイオ/素材/食品 - 臨床開発系
業種	製薬メーカー
勤務地	アジア日本東京都
仕事内容	Be part of one of the top global biopharmas in the industry. Take lead in the overall improvement of clinical QMS. Description * Leads Quality Planning & Implementation: Oversees all quality activities within Japan Development Operations (J-DO), ensuring alignment with global Clinical Quality Management Systems and adapting to regulatory and organisational changes. * Ensures Inspection Readiness: Guides study teams and collaborates with stakeholders to maintain a constant state of readiness for regulatory inspections (e.g., PMDA, EMA, FDA). * Drives Continuous Improvement: Collects and analyses quality data, leads issue investigations and CAPA development, and identifies opportunities for quality and process improvement. * Fosters Global Collaboration & Compliance: Acts as a global quality representative, ensuring consistent process application, managing compliance risks, and integrating regulatory updates into J-DO operations. * Champions Quality Culture: Serves as a professional role model, promotes ethical behaviour, simplifies procedural documentation, and builds strong relationships with internal and external partners. Profile * University degree in scientific or related field * High fluency in English and Japanese (non-native level speakers will not be selected) * Extensive experience in the pharmaceutical industry specifically in clinical QA * Ability to understand quality systems aligned with GCP * Knowledge in local regulations and compliance Job Offer * Competitive salaries and benefits * Great work life balance * Hybrid working style and international environment * Amazing career progression in clinical QA * Work with industry leaders who are solving various unmet medical needs Page Group Japan is acting as an Employment Agency in relation to this vacancy.
企業について（社風など）	* One of the top global biopharmaceutical companies in the industry * Rich development pipeline specializing in oncology, rare disease, cardiovascular, infectious diseases, etc. * Patient-centric and scientific focused organisation for various unmet medical needs * Hybrid working style * International environment with extensive global collaboration
英語能力	ビジネス会話 (TOEIC 735-860)
日本語能力	ネイティヴレベル
年収	日本・円 1200万円〜 1500万円