Quality System Specialist, Innovative Medicine (Fuji Plant)

About the role

Johnson & Johnson is hiring a Quality System specialist for the Quality System Group within the Quality Operations Department of the Manufacturing and Supply Division at its Fuji plant in Shizuoka. The role covers quality system and compliance activities under the Pharmaceutical Quality Law, GMP/GCTP regulations and corporate policies, and is open to internal candidates only.

Key responsibilities

• Manage GMP/GCTP activities such as data integrity, deviation management and change control
• Act as the point of contact with the Marketing Authorization Holder, maintain quality agreements, implement reporting requirements for deviations and manage audits
• Support other group members' GMP/GCTP and license management activities
• Carry out troubleshooting and prepare investigations of deviations
• Lead or support improvement initiatives and new projects

Required profile

• A degree in pharmacy, physical chemistry or biology is preferable
• More than 5 years of experience in quality control, quality assurance or regulatory compliance in the pharmaceutical industry is desirable
• Internal application only: read the internal application guidelines, get approval from your supervisor and BU HR before applying, and report any move to internal application after passing the first interview

Required skills

• Knowledge of GMP/GQP/QMS quality systems
• Business-level English is desirable
• Ability to use software applications such as MS Office and Trackwise
• Leadership, coaching, problem solving, project management and customer focus