QA Manager

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Job details

Company overview

Our client is a clinical-stage biotechnology company.

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