☑English language required
☑Japanese language required
Any company that have MAH business license for pharmaceutical drug must set position of Quality Responsible from regulatory requirement of PMD act. Quality Responsible is head of quality unit, quality assurance.
To Manage and lead the Quality related activities based on Japanese Pharmaceutical & Medical Devices Affairs Act, i.e. Quality Requirements of Ministerial Ordinance No.136, or Quality requirements in the LOC based on the global SOP and GSK's guidance, and lead the Deputy Quality Responsible.
Role-based Ad Hoc project tasks may be included, requiring to lead cross-functional activities with flexibility.
To take a role of decision making for cross-functional items as a member of Japan Leadership team (JLT).
This role is accountable to ensure the batch release of commercial pharmaceutical products to the market
- Comply with the requirement of GQP Ordinance and the related regulations
- Supervise and conduct quality assurance activities.
- Confirm that quality assurance operations are performed properly and smoothly.
- Ensure quality and manufacturing activities in manufacturing site listed in application form (to instruct improvement to manufacturer on product release, and evaluate/confirm for improvement)
- Handle quality information and incident
- Manage and lead product recall
- Implementation of Moc Recall enhancing consistent proceed
- Alliance with Global quality organizations
- Manage change control at manufacturing site including regulatory actions requirement as MAH
- Manage self-inspection
- Manage or approve Quality Standard, Quality Control Standard Operation Procedure/Quality Control Operation procedure and Quality Agreement with Manufacturers.
- Confirm periodically that the manufacturing control and quality control (including product release decision) of the relevant manufacturer, etc. are implemented properly and smoothly in accordance with the GMP law and quality agreement with the manufacturer, etc.
- Maintain business license by managing planned and non-planned GQP related inspection.
- Manage the Pharmaceutical affaires production dynamics monthly reporting to MHLW.
As a member of Japan Leadership team (JLT),
- to take a role of decision making for cross-functional items
- to manage and lead the role-based Ad Hoc project tasks flexibly.
- First Degree in scientific or engineering discipline
- Knowledge of GQP, GMP and QMS (Quality Management Systems)
- Solid understanding of Quality Management Systems (QMS), its application and business objectives.
- Good quality risk management and problem solving skills.
- Good leadership skills. Competent people manager. Able to engage, coach and develop staff.
- Strong interpersonal and influencing skills to achieve a solution.
- Experience of managing quality within an operations environment in pharmaceutical industry.
- Experience of working with and leading cross-site and multi-functional teams.
- Experienced auditor
[Preferred Knowledge, Skills and Abilities]
- Good understanding of commercial company business processes related to the QMS
- Experience and exposure/involvement with commercial activities
- Registered Pharmacist
- English Language level: Excellent oral and written communication skills. Able to work effectively in English.
- Japanese Language level: Fluent - Native Level (Equivalent to JLPT N1)
- Work permission in Japan required
10〜16 million JPY
※Experiences and skills will be considered
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.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance