Associate Director, Quality Assurance

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募集要項

会社概要

同社は、世界的な製薬企業の一部であり、医療・健康分野に特化した製品とサービスを提供しています。主に医薬品の研究開発、製造、販売を行い、疾病の治療や予防に貢献しています。革新的な医療技術と科学的アプローチに基づき、高度な研究と開発を進め、新たな治療法や医薬品を市場に提供しています。また、医療従事者や患者への教育活動や支援プログラムも展開し、医療の質の向上に寄与しています。グローバルに展開するネットワークを活かし、多様な地域と市場でのニーズに応え、持続可能な医療イノベーションを推進しています。

業務内容

• The Commercial Quality Lead - Japan has the overall Quality oversight & responsibility to ensure Quality and Regulatory compliance of all Commercialized Products, Japan LOC , Consumer related Distribution Centers and Warehouses within Japan base business, ensuring all applicable regulations as well as Enterprise Quality Policy Standards and procedures . The incumbent is also responsible for end-to-end Franchise Quality under Marketing Authorization and Quality Management System (QMS).
• This position is also responsible for Quality Assurance Supervisor (QP) who is accountable for quality assurance of Marketing Authorization products and reports to General Marketing Supervisor (SoSeki) in good collaboration with Safety Management Supervisor (AnSeki).

応募条件

Education and Qualification:

• Bachelors or Masters degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy.
• Pharmacist License

Experience:

• Over 10 years of direct related experience in quality assurance, quality related operations and regulatory compliance in regulated Pharmaceutical industry.
• Quality Assurance Supervisor experience in Pharmaceutical or Quasi-Drug if he/she is not Pharmacist
• People management experience.
• Regulatory inspection experience.

Other Preferred Competency and Skills:

• Demonstrated ability to manage relationship development and maintenance and negotiation skills.
• Comprehensive knowledge of Japanese regulations applicable to Drug, Quasi-drug and Cosmetics.
• Written and verbal communication skills in English.
• Good communication capability to facilitate effective interaction and motivate the team members.
• Self leadership and motivation with high personal integrity and application of Johnson & Johnson value.

給与

600 - 1000 万円

勤務地

東京