[quality] Quality Supervisor, Quality Assurance [amo]

Johnson & Johnson Johnson & Johnson · Pharma · Chiyoda, Tokyo, Japan

Quality Supervisor for Johnson & Johnson's healthcare products (medical devices, pharmaceuticals) in Tokyo, Japan. Focuses on building, maintaining, and improving the quality management system, ensuring compliance with Japanese regulations (e.g., Pharmaceutical and Medical Device Act, GQP, QMS, GMP) and J&J's internal standards. Responsibilities include leading quality system processes, acting as a Subject Matter Expert, managing product quality and safety for market release, overseeing manufacturing quality control, conducting audits, managing documentation, supporting recalls, and preparing for regulatory inspections. Requires experience in QA/QC in the medical device/pharma industry, knowledge of relevant regulations, and strong leadership and communication skills.

What you'd actually do

  1. Lead the construction, maintenance, and improvement of quality system processes, focusing on ensuring the quality management system is appropriately established, operated, and complied with within the company.
  2. Operate and manage assigned quality system processes as a Subject Matter Expert (SME), collaborating with domestic and international stakeholders, and lead responses to administrative audits.
  3. Ensure the quality and safety of products shipped to the market as a marketing authorization holder, and manage activities related to manufacturing control and quality control at domestic and overseas manufacturing sites.
  4. Participate as a lead auditor in internal and supplier audits.
  5. Manage and lead quality improvement activities with domestic and overseas manufacturers.

Skills

Required

  • Business level English (speaking, reading, writing)
  • High communication skills and strong leadership ability
  • Ability to lead the growth of team members
  • Strong commitment to task execution, with speed and flexibility
  • General PC skills
  • Knowledge and operation of internal systems (Agile, SAP, EtQ, ComplianceWire, SUMMIT, One ASL, Curve, HPE, etc.)
  • Knowledge of J&J Standards, JJ Vision Franchise requirements, GxP documents
  • Up-to-date knowledge of relevant ministerial ordinances and notifications such as medical device related regulations, GQP, QMS, GMP
  • Deep product knowledge
  • Knowledge and experience to lead audits as a lead auditor
  • Set Vision & Strategy: Learn new and changing business processes, tasks, and trends and apply them appropriately to work
  • Anticipate: Proactively identify business issues and obstacles, communicate them to leaders and colleagues, and develop appropriate emergency response measures
  • Innovate: Seek and integrate diverse opinions and perspectives to create better ideas and solutions
  • Build: Continuously develop talents, skills, and abilities. Eliminate resistance to receiving and giving constructive feedback with colleagues and partners. Enhance communication and influence to create a significant impact on others
  • Deliver Results: Comply with quality and compliance standards

Nice to have

  • Compliance Management
  • Corrective and Preventive Action (CAPA)
  • Cross-Functional Collaboration
  • Detail-Oriented
  • Developing Others
  • Give Feedback
  • Goal Attainment
  • Human-Centered Design
  • Inclusive Leadership
  • Internal Controls
  • Leadership
  • Process Oriented
  • Quality Control (QC)
  • Quality Management Systems (QMS)
  • Quality Standards
  • Risk Assessments

What the JD emphasized

  • compliance with relevant regulations and standards and internal regulations (J&J Corporate Standard and JJ Vision Franchise requirements)
  • Subject Matter Expert (SME)
  • lead responses to administrative audits
  • ensure the quality and safety of products shipped to the market
  • manufacturing control and quality control
  • lead internal and supplier audits
  • lead quality improvement activities
  • support domestic quality operations manager / quality assurance manager
  • lead the preparation, execution, and post-audit response for inspections by supervisory authorities, JJRC audits, and Franchise audits
  • lead quality management system and quality assurance related operations
  • Knowledge of Pharmaceutical and Medical Device Act, GQP, QMS, GMP ministerial ordinances
  • Lead internal and supplier audits
  • lead quality improvement activities
  • support domestic quality operations manager / quality assurance manager
  • lead the preparation, execution, and post-audit response for inspections by supervisory authorities, JJRC audits, and Franchise audits
  • lead quality management system and quality assurance related operations
  • Knowledge of Pharmaceutical and Medical Device Act, GQP, QMS, GMP ministerial ordinances