Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Chiyoda, Tokyo, Japan

DePuy Synthes is recruiting for a HSD Specialist – Commercial Quality, located in Chiyoda, Tokyo

The HSD Specialist – Commercial Quality is responsible for supporting Health, Safety, and Distribution (HSD)–related quality activities for commercial operations in Japan. This role helps ensure that distribution, handling, and post‑market activities comply with applicable regulatory requirements, quality system standards, and internal procedures. The position plays an important role in safeguarding patient safety, maintaining regulatory compliance, and supporting reliable product supply by partnering closely with Commercial, Regulatory Affairs, Quality, and Supply Chain teams.

Key Responsibilities

• Support HSD‑related commercial quality activities to ensure compliance with regulatory requirements, quality system standards, and internal policies.
• Provide quality support for distribution, storage, handling, and logistics activities in the local market.
• Partner with Supply Chain and Commercial teams to support compliant product distribution and lifecycle activities.
• Support post‑market surveillance activities, including complaint handling, investigations, and field action support as required.
• Participate in internal audits, external audits, and health authority inspections related to HSD and commercial quality processes.
• Monitor quality issues, trends, and risks related to distribution and handling activities and support corrective and preventive actions.
• Ensure accurate maintenance of quality documentation, records, and reports related to HSD and commercial quality activities.
• Contribute to continuous improvement initiatives to strengthen compliance and operational effectiveness.

Qualifications

Education:

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, or a related discipline (required).
• Advanced degree in a scientific, quality, or regulatory field (preferred).
  

Experience and Skills:

Required:

• Typically 0-2 years of experience in Quality, Regulatory, or Compliance roles within a regulated industry.
• Foundational understanding of quality system requirements and regulatory expectations for commercial operations.
• Experience supporting distribution, logistics, or post‑market quality activities.
• Ability to interpret quality procedures and regulatory requirements and apply them to daily work.
  

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.
• Familiarity with Japanese regulatory and quality requirements.
• Experience working in a multinational or matrixed organization.
• Exposure to health authority interactions or regulatory inspections.
• Quality or Regulatory certifications (e.g., RAC).
• Strong attention to detail, documentation, and organizational skills
• 
  

Other:

Language: Japanese required; English proficiency preferred.

Travel: Limited; occasional domestic travel within Japan.

Certifications: Quality or Regulatory certifications preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Required Skills:

Preferred Skills:

Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing