更新日 2025-05-02
掲載開始日 2025-05-02

External Quality Associate Director @ Global Leading Biopharma

NEW

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 - 生産技術/生産管理
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 quality management for external suppliers/manufacturers. Description * Oversee and manage the quality activities of assigned external suppliers within procurement Quality global teams, including change control, product quality complaints, and issue management. * Ensure the establishment and maintenance of quality Agreements between the business and external suppliers, as well as company Operations Sites. * Support Quality Professionals in managing supplier and product supply chain quality within assigned categories. * Prepare and submit supplier quality assessments, and handle regulatory agency interactions, including inspections at external suppliers and company sites. * Lead quality initiatives for NPI, new supplier introductions, strategic sourcing, process optimization, and product transfer projects related to supplier quality management. Profile * University degree in scientific or related field * Experience in QA in the global pharmaceutical industry * Strong understanding of cGMPs, QMS, and other GxPs * High fluency in English and Japanese (non-native level speakers will not be selected) * Ability to work cross functionally as well as communicate with global stakeholders * Rich understanding of local regulations/compliance Job Offer * Competitive salaries and benefits * Great work life balance * Hybrid working style and international environment * Amazing career progression in 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