QA Manager

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Job details

Company overview

We are engaged in the research, development and provision of medical technologies in Japan. In particular, we focus on the development of innovative therapies and provide advanced technologies related to cancer treatment. We use a new therapeutic approach called photoimmunotherapy to target cancer cells for effective treatment. This technology combines light and drugs to selectively destroy cancer cells. In research and development, we are strengthening our collaboration with specialized institutions and universities in Japan and overseas to conduct clinical trials and commercialize the technology. We are committed to innovation in the medical field and to improving the quality of life of patients.

Responsibilities

• Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
• When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
• Ensure full compliance with applicable regulations in Japan.
• Oversee all activities or responsibilities that are delegated to external parties.

Requirements

• 5+ years Knowledge of relevant in Quality Assurance in healthcare industry.
• Experience of complaint handling
• Experience in both clinical and post-marketing environment.
• Understanding of PMD Act, relevant regulations and guidelines.
• Thorough knowledge of drug and medical device development process.
• Very good communication and problem solution skill among cross-functional team.
• Ability to communicate reading, writing, and speaking in English is strongly preferred. (Target : TOEIC score above 800 )
• Bachelor's Degree in Science or related discipline
• Knowledge of relevant in Quality Assurance in pharma industry is plus.
• Strong Communication skill with external parties.

Salary

10 - 12 million yen

Location

Tokyo