募集要項
- 募集背景
- 戦力強化のため。
- 仕事内容
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多数の革新的な製品を有する外資系バイオ製薬会社で、免疫細胞療法事業部門のQuality Assurance（QA）【シニアマネジャー】職を募集いたします！配属部署：免疫細胞療法事業部門
ご応募をお待ちしております。
We are seeking a highly motivated individual to join us as Senior Manager, Quality Assurance/ Responsible Person 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 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.
・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)
・Responsible for tracking and reporting metrics
- 応募資格
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- 必須
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・Bachelor’s degree in medicine, dentistry, pharmacy, veterinary medicine, or biology or related field
・Minimum of 7 years progressive experience in medical, pharmaceutical or biologics quality systems’ roles
・Eligible for GMCO role
・Minimum of 2-3 years of management/leadership experience
・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
・Proficiency for reading and writing in English
・Strong working knowledge of and ability to apply cGMP principles in conformance to Japanese and US
・Comfortable interacting with regulatory agencies as needed
・Proficient in MS Word, Excel, and Power Point
- 歓迎
- ・Experience with product import lot disposition, deviation and change control management preferred
- フィットする人物像
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・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
- 雇用形態
- 正社員
- ポジション・役割
- Quality Assurance（QA）【シニアマネジャー】
- 勤務地
- 東京本社
- 勤務時間
- 9:00～18:00 フレックス制度あり
- 年収・給与
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1400万円～1600万円（目安） 年俸制
※インセンティブボーナス含む。別途、RSUあり。
※別途、該当者には単身赴任手当等あり。
- 待遇・福利厚生
- 通勤手当、健康保険、厚生年金保険、雇用保険、労災保険、退職金制度、確定拠出年金制度、ベネフィットステーション
- 休日休暇
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完全週休2日制（休日は土日祝日）、年間有給休暇12日～20日（下限日数は、入社直後の付与日数となります）
年間休日日数125日、年末年始休暇、グローバル休暇、有給休暇は初年度は入社日により最大12日付与、傷病休暇
- 選考プロセス
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【選考プロセス】書類選考⇒面接（3回）⇒内定
【仕事内容の続き】
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・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.))
・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
・Support recruit, manage and develop Quality Operation team
・Collaborate cross-functionally with the Japan affiliate to fulfill all responsibilities as MAH.
・Perform other duties as assigned
