Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob 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
1. 90% - Establish the system and manage QMS system, including the management of NC/CAPA, Internal Audit management, Quality system management review, and audit response.
2. 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