MANDATORY

• Applicants must have permission to work in Japan
• Applicants must be able to speak fluent ~ native level Japanese (Equivalent to JLPT N1)

☑Japanese global company ☑English language required ☑Japanese language required

[Position]
Medical QA Manager

[Company Description]
Global Biotechnology Company

• Developing precision, cell-targeting investigational therapies on its technology platform, which utilizes antibodies conjugated with payloads that are specifically activated at the tumor site.

[Position Summary]

• This position will directly report to Quality Assurance supervisor Japan and have responsibility for leading the execution of all Quality Assurance (GQP/QMS) activities.

[Responsibilities]

• Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device and drug perspective.
• Contribute to Product life cycle management in a global organization, among global/domestic companies (change management, quality agreement, audit, quality issue handling, CAPA etc.)
• Ensure full compliance with applicable regulations in Japan.
• Oversee all activities or responsibilities that are delegated to external parties.

[Requirements]
Mandatory:

• 5+ years Knowledge of relevant in Quality Assurance in healthcare (pharmaceutical or medical devices) industry.
• Experience quality operations listed below in post-marketing and/or manufacturing environment. o Quality information handling such as complaint, deviation, CAPA etc.

o Improvement of quality processes as shown the above
o Establish, revise or maintain SOPs
o Auditing suppliers
o Inspection by authorities

• Understanding of PMD Act, relevant regulations and guidelines.
• Thorough knowledge of drug and/or medical device development process.
• Experience communication in English with business partners, ability to communicate reading, writing, and speaking in English is strongly preferred. (as ref.; TOEIC score above 800)
• Bachelor's Degree in Science or related discipline

Preferred skills and experience:

• Knowledge of relevant in Quality Assurance in pharma industry is plus.

[Location]
Tokyo

[Salary]
8 million JPY - 11 million JPY (Experiences and skills will be considered)

[Welfare]
Social insurance

[Holidays]
Full 2 holiday week system (Sat/Sun), National holidays, New year's holiday, Annual Leave

[Selection Process]
Application screening and several interviews are scheduled.

Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.

Reference: JO-2304-480770
#LI-Onsite
Seniority Level:Mid-Senior level
Job Function: Health Care Provider, Quality Assurance, Management