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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
Job Description
SCOPE OF THE ROLE AND BASIC PURPOSE
▪ Maintain JJKK Quality Management Systems with highest level of compliance to Japanese regulations and J&J Quality Policies by analysing quality metrics, improving company procedures, train the employees and audit internal/external organizations. This role also needs to work together with other sectors (CON/Vision/JAN etc.), where needed, to maintain J&J Japan to be compliant with Japanese regulations.
▪ Maintain all business licenses which are required for JJKK business including but not limited to Marketing Authorization Holder (MAH) licences for Pharmaceuticals, Medical Devices.
▪ Address audits by internal (JJRC) and external auditing organizations (PMDA, TMG, TUV etc.)
▪ Responsible a couple of Quality Systems elements as “Process Owner”.
**KEY RESPONSIBILITIES/TASKS **
90% - Establish the system and manage QMS system, including the management of NC/CAPA, Internal Audit management, Quality system management review, and audit response.
10% - Audit Management
**Required Competencies and Skills **
▪ Excellent Communication skill in Japanese (interaction with auditors, government officials and internal stakeholders)
▪ Logical Thinking/Decision Making
▪ Good English Communication
**Required Skills: **
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing