募集要項
- 募集背景
- 新規募集。
- 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Site Qualification（サイトQA）【マネジャー/シニアマネジャー】職の募集です！We are seeking highly motivated individuals to join us as Manager － Senior Manager, Quality Assurance （Hospital Site Qualifications） to support the Japan market. You will work with the Quality and Commercial teams in supporting our efforts in this exciting new area of cancer immunotherapy.
製薬業界での品質監査、サイトマネージャーのご経験者歓迎。
You will work cross functionally and as part of a global team to assist with the qualification and monitoring program for hospitals performing apheresis and treatment （ATC） who are already working or intend to work with Kite CAR－T cell products. In addition, as required, you will be responsible for performing and addressing quality systems aspects related to qualification and monitoring of apheresis centers and treatment site （ATC）.
This position will be located in Tokyo, Japan; reporting to the Associate Director, Product and Distribution Quality （Corporate Quality Assurance）, at in Tokyo, Japan.
・Perform new site qualifications （including audits and trainings） and monitoring of authorized ATC.
- 応募資格
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- 必須
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・Bachelor’s degree in Nursing, medical technology, biological sciences or related field
・Minimum of 5 years progressive experience in medical, pharmaceutical or biologics quality systems’
roles;apheresis/transplant/infusion centers, blood banks, nursing, or blood/human tissue experience
preferred
・Experience auditing blood banks, plasma centers, apheresis centers, external suppliers and/or internal GMPsystems.
・Reading and writing English or higher
・Proficient in MS Word, Excel, and Power Point
・Experience with Quality information systems （eg, Veeva, Agile, Trackwise）
・Strong working knowledge of and ability to apply GMP in conformance to Japanese requirements.
・Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- 歓迎
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・Master’s degree preferred
・Previous experience presenting and responding to regulatory agency audits, preferred.
・Experience in areas such as Clinical Research, Medical Liaison, Apheresis and Cell Therapy Medical Centers preferred.
- フィットする人物像
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・Comfortable in a fast－paced 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
- Site Qualification（サイトQA）【マネジャー/シニアマネジャー】免疫細胞療法部門
- 勤務地
- 東京本社（全国への出張あり）
- 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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1000万円～1200万円（目安） 年俸制
※インセンティブボーナス含む。別途、RSUあり。
※別途食事手当あり
※居住地は特定しません（居住エリアから全国出張となります）
- 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
