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To manage the whole operations of the production site in Japan. By co-working with the global sites in the US and Europe, you will ensure that the quality standards of production will be at top level.
Join our global client organization as the Senior Manager or Associate Director of Biostatistics, where you'll leverage your statistical expertise to lead and support clinical trials in Japan. Utilize your fluency in Japanese and business-level English to collaborate with both local and overseas teams, contributing to the advancement of global clinical research.
To apply regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site for products manufactured in Japan with the aim to export to overseas markets (APAC&Europe)
Take lead in ensuring effective quality compliance of clinical trials being conducted overseas. Review materials, data, and other documents to align GCP.
Take lead in building, maintaining, improving QMS. Ensuring quality and safety of products from local and overseas manufacturing sites.
To lead the whole packaging operations of the production site. Their products are mainly solid tablets and you will have the chance to lead a multidisciplinary team with several overseas connections.
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