Quality Lead (Associate Director)/CMC薬事 【製薬オンライン】製薬会社・製薬メーカー・製薬企業・医薬品・医療機器等の製薬・医療業界の求人転職サイト

受付時間 平日9時~20時まで 土曜9時~17時まで 03-6278-8721

製薬業界専門の転職・求人サイト 製薬Online.com
最終更新日: 2018年 05月 28日
春の転職支援キャンペーン 期間:2018年1月26日(金)から4月30日(月)





Quality Lead (Associate Director)

responsible for Quality oversight of clinical and commercial cell therapies intended for the Japanese market


Ensure cell therapies manufactured are produced, tested, and released in compliance with SOPs, cGMPs and local
・Make decisions regarding quality and compliance for all cell therapy products including release and reject decisions
・ Negotiate and maintain the Quality Agreement and ensure compliance with their terms
・Provides support and acts as point of contact during regulatory health inspections as needed
・Leads inspection readiness activities in collaboration with other functional groups
・ Develop and implement Quality metrics and assess the metrics as part of a cross functional team
・Prepare and maintain the overall budget for the Quality organization
・ Support contract partner assessments and new product implementations
・Provide quality oversight for raw materials, components, and cell therapies
・ Represent quality on the CMC teams and provide input into CMC planning, coordination, and decision making
・ Ensure compliance with internal standards and regulatory requirements
・ Provide technology transfer and validation support
・Fianl approver of all GMP documents requiring Quality approval including Investigations, Change Controls, Validation
Documents, Specifications, Complaints, Master Batch Records


  • ・Must have expert GMP, Quality, and risk management knowledge
    ・ Knowledge of cGMP’s and multi-national biopharmaceutical/cell therapy requirements
    ・ Experience working with external partners and leading cross-functional teams
    ・ Ability to make independent and objective decisions and to work with minimal supervision
    ・ Strong verbal/written communication skills and ability to influence at all levels
    ・ Ability to think strategically and to translate strategy into actions/deliverables and timelines
    ・ Ability to prioritize and provide clear direction to both internal and external team members
    ・ Knowledge of Operational Excellence and Lean Manufacturing (preferred)
    ・Bachelor’s Degree required (related science is preferred)
    ・ 8 or more years of work experience in the biopharmaceutical or related industry
    ・6 or more years of QA/QC or related experience in the biopharmaceutical industry
    ・ Fluency in the Japanese language


  • 応相談


  • 1


  • 正社員


  • 東京


  • なし


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