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

Johnson & Johnson Innovative Medicine

Shizuoka, Japan
Hybrid
Nc/capa investigation and approval
Quality systems compliance
Root cause analysis and corrective actions
Johnson & Johnson's Innovative Medicine division is seeking a Senior Quality Specialist to lead non-conformance and corrective/preventive action (NC/CAPA) investigations in a hybrid work environment. The role involves ensuring compliance, facilitating investigations, and collaborating with stakeholders across 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 monitoring progress, provides feedback to investigation and CAPA owners, resolves stakeholder conflicts, and escalates issues to senior management when required.
  • The position requires collaboration with multiple stakeholders to sustain processes, support audits and inspections, and drive continuous quality improvement.

Matching Summary

Match Score: 85

Johnson & Johnson's Innovative Medicine division is seeking a Senior Quality Specialist to lead non-conformance and corrective/preventive action (NC/CAPA) investigations in a hybrid work environment. The role involves ensuring compliance, facilitating investigations, and collaborating with stakeholders across the supply chain.

Skills & Requirements

Must-have

  • NC/CAPA investigation and approval
  • Quality Systems Compliance
  • Root cause analysis and corrective actions
  • Data analytics and trending
  • Cross-functional stakeholder collaboration
  • Audit and inspection readiness

Nice-to-have

  • Coaching and feedback skills
  • Risk management understanding
  • Strong communication and writing
  • Project and process management
  • Strategic thinking and problem solving
  • Relationship building and negotiation

Key Requirements

  • Bachelor’s Degree in Life Science or related discipline
  • Minimum 6 years in regulated MedTech or Pharmaceutical Quality Systems
  • Experience as investigator of NC/CAPA process
  • Knowledge of regulatory compliance
  • Excellent communication and writing skills

Work Rights

Not specified

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