Improve cell-product manufacturing and analytical methods, manage outsourced production and testing, and support regulatory submissions and technology transfer.
About this role
SanBio is hiring a quality-assurance manager or senior manager for regenerative-cell products. Appointment level depends on experience, and the role supports the quality-assurance head.
Responsibilities include GQP and QMS operation, audits and training, corrective actions, quality reporting, authority interactions, release decisions, change control, complaints and recalls. Maintaining procedures, overseeing suppliers and developing department members are also included.
Applicants need at least seven years in regenerative medicine, pharmaceuticals or medical devices and three years in the specified quality work: GQP systems and SOPs for drugs or regenerative products, contract-manufacturer coordination and inspection responses. Business English reading and writing and a science master’s degree or higher are required. Pharmacist credentials and people management are preferred. The position is in Akashicho, Tokyo, with coreless flexitime. Salary and remote-work availability are not disclosed.
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