[innovative Medicine] Specialist, Quality System 2 Group, Quality Operations Dept., Manufacturing And Supply Div. (fuji Plant)

Johnson & Johnson

Shizuoka, Japan
Onsite
Gmp/gctp regulatory compliance
Data integrity management
Deviation and change control
Johnson & Johnson is seeking a Quality System Specialist for their innovative medicine division at the Fuji Plant in Shizuoka, Japan. The ideal candidate will have a strong background in quality assurance and regulatory compliance in the pharmaceutical industry, with at least five years of experience. This role offers an opportunity to work in a company committed to healthcare innovation and a diverse, inclusive work environment

Job Summary

  • This role involves performing quality system and compliance-related activities in accordance with GMP/GCTP regulations and corporate policies.
  • The specialist acts as the primary point of contact with the Marketing Authorization Holder for maintaining quality agreements and managing audit requirements.
  • Candidates are expected to lead or support new initiatives while ensuring data integrity and effective deviation management within the pharmaceutical manufacturing environment.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Quality System Specialist for their innovative medicine division at the Fuji Plant in Shizuoka, Japan. The ideal candidate will have a strong background in quality assurance and regulatory compliance in the pharmaceutical industry, with at least five years of experience. This role offers an opportunity to work in a company committed to healthcare innovation and a diverse, inclusive work environment.

Skills & Requirements

Must-have

  • GMP/GCTP regulatory compliance
  • Data Integrity management
  • Deviation and Change Control
  • Audit management experience
  • Trackwise software proficiency

Nice-to-have

  • Business-level English proficiency
  • Leadership and coaching skills
  • Project management capabilities
  • Troubleshooting and investigation
  • Continuous improvement initiatives

Key Requirements

  • Degree in Pharmacy, Physics, Chemistry, or Biology
  • 5+ years experience in Quality Assurance or Regulatory Compliance
  • Knowledge of GMP/GQP/QMS quality systems

Work Rights

Not specified

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