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**Job Function: **
Quality
**Job Sub Function: **
Customer/Commercial Quality
Job Category:
Professional
All Job Posting Locations:
Chiyoda, Tokyo, Japan
Job Description:
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.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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**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