HSD Specialist

Johnson & Johnson

Job Location:

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 13 days ago

Vacancies: 1 Vacancy

Job Summary

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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

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 postmarket 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 HSDrelated 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 postmarket 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:

Bachelors 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 postmarket 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 .

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 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 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

Required Experience: