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Specialist / Manager, QA－ Kite

年収：応相談

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部署・役職名	Specialist / Manager, QA－ Kite
職種	生産技術・生産管理・製造技術 QC（品質管理） QA（品質保証）
業種	医薬品メーカー
勤務地	東京都
仕事内容	Job Level：Manager Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Kite department in Gilead Sciences is a biopharmaceutical department engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The Kite in Gilead is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. For the activities in Japan Kite in Gilead is currently looking for a talent as it focuses on developing the Cell Therapy program in Japan in support of providing maximum access to patients with unmet needs. Position Summary We are seeking a highly motivated individual to join us as Manager or Sr. Specialist for Japan. You will work in the Quality and collaborate with Commercial teams in supporting commercial operation in this exciting new area of cancer immunotherapy. This individual will work cross functionally to implement, improve, and execute the Good Quality Practice for Kite in Gilead Japan. Your responsibilities will include local release of products imported into Japan from the manufacturing sites, managing local QMS, and other duties as assigned to comply with local legislation and company requirements. This position will be in Japan, reporting to Associate Director, Quality Assurance at Kite in Gilead Sciences. Responsibilities (include but are not limited to) ・Responsible for market release of Cell Therapy Finished Products in Japan and quality monitoring of importation of Cell Therapy Finished Products in Japan ・Maintain and update local QMS/ GQP to adhere local regulation (e.g. PMDA) ・Provides QA oversight and approves deviations, change controls and product complaints investigations for the manufacture, packaging and shipping events impacting Cell Therapy ・Products for Japan when applicable ・Provides information, guidance or reports to management when specific compliance issues arise ・Oversee and interface with Japan CMO to address and resolve performance issues and quality events. ・Maintain metrics related to Quality of Commercial Cell Therapy Product(s) ・Act as Japan lead or support for Japan health authorities (PMDA, etc.) inspections, product complaints, deviations, or recall/Field Corrective Actions (reporting to Japan health authorities (PMDA, etc.)) ・Responsible for tracking and reporting metrics ・Support inspection readiness plans and interact with regulatory agencies during inspections on Kite related matters ・Lead for affiliate Kite GMP self-inspections ・Conduct and manage internal or external audits ・Work with Regional and Corporate (Quality) teams, as needed ・Collaborate cross-functionally with the Japan Gilead affiliate to fulfill all responsibilities as MAH. ・Perform other duties as assigned
労働条件	Quality Regular Full Time/Part Time：Full-Time Japan - Tokyo Remote Type：Onsite - Hybrid Eligible
応募資格	【必須（MUST）】＜Requirements＞・Bachelor’s degree in medicine, dentistry, pharmacy, veterinary medicine, or biology or related field ・Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles ・Experience with product import lot disposition, deviation and change control management preferred ・Proficiency for reading and writing in English and Japanese ・Strong working knowledge of and ability to apply cGMP principles in conformance to Japanese and US ・Broad experience across areas like Quality Assurance and/or Quality Systems and understanding of parenteral and aseptic operations is beneficial ・Previous experience presenting and responding to regulatory agency inspections ・Comfortable interacting with regulatory agencies as needed ・Proficient in MS Word, Excel, and Power Point ・Comfortable using web-based systems and digital tools as part of daily work operations. ・Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment ・Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities ・Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
アピールポイント	フレックスタイム
受動喫煙対策	喫煙室設置
更新日	2025/12/25
求人番号	6145073

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