[innovative Medicine] Sr. Qa Specialist, Imsc Nc Capa

J&J FAMILY OF COMPANIES

Shizuoka, Japan
Hybrid
Nc/capa investigation and approval
Quality management systems (qms)
Root cause analysis and corrective actions
Johnson & Johnson is seeking a Senior Quality Assurance Specialist for their Innovative Medicine division in Shizuoka, Japan. The role focuses on leading non-conformance and corrective/preventive action investigations to ensure compliance and quality within the supply chain

Job Summary

  • The Sr. Quality Specialist leads robustness of NC/CAPA investigations and approvals, ensuring timely initiation, thorough root-cause analysis, and effective corrective/preventive actions across Innovative Medicine Supply Chain sites.
  • This role supports training, facilitates investigation initiation, monitors progress, executes quality review duties, and collaborates with stakeholders to maintain inspection readiness and support audits.
  • The position requires excellent communication, analytical skills, and the ability to work independently in a matrixed environment while driving compliance to global quality processes.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Senior Quality Assurance Specialist for their Innovative Medicine division in Shizuoka, Japan. The role focuses on leading non-conformance and corrective/preventive action investigations to ensure compliance and quality within the supply chain.

Skills & Requirements

Must-have

  • NC/CAPA investigation and approval
  • Quality Management Systems (QMS)
  • Root cause analysis and corrective actions
  • Regulatory compliance in MedTech or Pharma
  • Data analytics and trending
  • Cross-functional stakeholder collaboration

Nice-to-have

  • Coaching and feedback skills
  • Project Management and Process Excellence
  • Strong communication and writing skills
  • Risk management understanding
  • Ability to build consensus and influence
  • Adaptability and attention to detail

Key Requirements

  • Bachelor’s Degree in Life Science or related discipline
  • Minimum 6 years experience in regulated MedTech or Pharmaceutical Quality Systems
  • Experience as investigator of NC/CAPA process
  • Knowledge of regulations and regulatory compliance
  • Strong analytical and problem-solving skills

Work Rights

Not specified

Tailored Resume

Cover Letter