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About the Role
Johnson & Johnson is dedicated to improving global health through healthcare innovation. This role is crucial in ensuring compliance and developing an effective Quality Management System (QMS) that meets stakeholder needs and drives value.
Responsibilities
- Ensure compliance with applicable domestic and international regulations, standards, and quality requirements.
- Develop and maintain an effective Quality Management System (QMS).
- Execute quality system activities including document control, change management, audit management, QMS-related training, and business license management.
- Develop and implement initiatives that deliver value to internal stakeholders and customers through the QMS.
- Proactively identify and understand customer needs, business requirements, and organizational changes.
- Build strong and trusted relationships with stakeholders, including global partners.
- Establish simpler, more efficient, and reliable QMS processes.
Requirements
- Knowledge and practical experience of laws and QMS ministerial requirements.
- Proactive approach and ability to 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.
- Strong commitment to achieving goals and flexible ability to execute.
- Native verbal and written communication skills in Japanese.
- 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 (preferred).
- English skill in business level (preferred).
- Experience in a global/cross-culture environment (preferred).
- IT/Digital literacy (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
Location
- Chiyoda, Tokyo, Japan
Work Type
- Full-time
Experience Level
- 3+ years preferred
Education Level
- Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).
About the Company
- Johnson & Johnson believes health is everything and strives to build a world where complex diseases are prevented, treated, and cured through healthcare innovation.
- The company has expertise in Innovative Medicine and MedTech, positioning it to innovate across the full spectrum of healthcare solutions.
- Johnson & Johnson is committed to providing an inclusive work environment where employees are respected for their diversity and dignity.
- Johnson & Johnson announced plans to separate its Orthopaedics business to establish a standalone company, DePuy Synthes.
- If hired, employees may transition to DePuy Synthes following the completion of the separation.
Equal Opportunity
- 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.