Innovative Medicine Specialist, Quality System 2 Group, Quality Operations Department, Manufacturing and Supply Division (Fuji Plant)

Location: Shizuoka, Japan; onsite at the Fuji Plant

Company

Johnson & Johnson MedTech develops healthcare solutions across Innovative Medicine and MedTech to improve patient outcomes.

What you will do

• Manage GMP/GCTP quality system activities, including data integrity, deviation management, and change control.
• Act as the point of contact with the Marketing Authorization Holder and maintain quality agreements.
• Implement reporting requirements for deviations and related events and support audit management.
• Support GMP/GCTP and license management activities performed by other group members.
• Prepare and conduct troubleshooting and deviation investigations.
• Lead or support improvement initiatives and new projects.

Requirements

• More than five years of experience in pharmaceutical quality control, quality assurance, regulatory compliance, or related areas.
• Knowledge of GMP, GQP, and QMS quality systems.
• Business-level English proficiency is desirable.
• Degree in pharmacy, physics, chemistry, or biology is desirable.
• Ability to use software applications such as Microsoft Office and TrackWise.
• Leadership, coaching, problem-solving, communication, collaboration, teamwork, project management, and customer focus.

Culture & Benefits

• Work in an inclusive environment that respects diversity, dignity, and individual merit.
• Contribute to healthcare innovation and the development of future medicines.
• Collaborate across quality operations, manufacturing, supply, and regulatory functions.