[Quality] Supervisor, Quality & Regulatory Compliance [Orthopaedics]

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:

Quality

Job Sub Function:

Quality Systems

Job Category:

People Leader

All Job Posting Locations:

Chiyoda, Tokyo, Japan

Job Description:

Key Responsibilities

 Ensure compliance with applicable domestic and international regulations, standards, and quality requirements. Develop and maintain an effective Quality Management System (QMS) that addresses the needs of internal stakeholders and execute quality system activities in accordance with established procedures, including document control, change management, audit management, QMS-related training management and business license management.

In addition, develop and implement initiatives that deliver value to both internal stakeholders and customers through the QMS. Proactively identify and understand customer needs, business requirements, and organizational changes, while building strong and trusted relationships with stakeholders, including global partners, to establish simpler, more efficient, and reliable QMS processes.

Experience and Skills:

Required:

• Knowledge and practical experience of laws and QMS ministerial requirements
• Proactive approach/ Able to appropriately demonstrate unique initiatives
• Ability to work both independently and in collaboration with others.
• Logical thinking, decision making, problem-solving skills, positive thinking, and attitude to learn new things.
• Has a strong commitment to achieving goals and a flexible ability to execute.
• Native verbal and written communication skills in Japanese.

Preferably:

· At least 3 years of experience in Quality Assurance, Vigilance Safety, Regulatory Affairs or Quality System function within the regulated Medical Device or Pharmaceutical industry

·  English skill in business level.

·  Experience in global/cross culture environment

·  IT/Digital literacy

Education:

•     Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).

"Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.”

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Collaboration, Communication, Compliance Management, Data Quality, Data Savvy, Developing Others, Document Management, Inclusive Leadership, Leadership, Operations Management, Performance Measurement, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People