Manager, Quality Assurance, Cell & Gene (CAR-T)

Company Overview
◆グローバルランキング5位以内
◆ヨーロッパヘッドクオーター
◆癌、呼吸器、循環器、眼科領域を始め幅広い領域にパイプラインを持つ
◆癌領域に最先端の技術

Job Description
Job Purpose
・ Responsible for managing quality aspects at Apheresis sites and transporter for Apheresis materials
・ Training of sites on QA aspects
・ Ensure that all aspects of the handling, manufacturing and distribution of apheresis materials are in compliance with the Company's Standards, with the effective Quality Agreement. Ensure that activities at apheresis site and transporter are conducted according to the relevant SOPs.
・ Coordinate sites for internal audit.
・ Communicate directly with Cell processing site (Morris Plains) to handle deviations at Apheresis site

Major Accountabilities
・ Compliant running sites
・ Passing of internal/external audits
・ Manufacturing not interrupted because of non compliant operation

Requirements
・ Bachelor or higher in Biology, Biochemistry or another related science
・ Fluent in speaking / writing in English
・ Experience in QA Operations, production, QC and/or regulatory other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience
・ Knowledge of cGMP requirements
・ Strong understanding of regulatory requirements for commercial products
・ Proven track record with PMDA and other Health Authorities
・ Strong Technical understanding of pharmaceutical processes

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