Johnson & Johnson Careers

【Janssen】Business Quality Product Quality Complaints Sr Specialist

Chiyoda, Japan
Quality Assurance

Job Description

Requisition ID: 1805704702W

Overall purpose of job:

This role aims to ensure key compliance requirements for GQP ordinance in Japan and J&J global standards for Business Quality (BQ). The role will play a key role in management of product quality complaints as per MHLW expectations as Marketing Authorization Holder, and J&J global standards.


Essential duties and responsibilities:

Responsibilities include, but not limited to:

  1. Manage product quality complaints from customers in compliance with the procedures and relevant regulations, and report (escalate) the information to the Quality Assurance Manager appropriately.
  2. Manage product quality complaints intake process and Trackwise records until completion.
  3. Lead development of communication with the customers.
  4. Work with Medical Representatives in appropriate communication with customers.
  5. Review acceptability of complaints investigation reports to closure.
  6. Work with Pharmacovigilance on combined adverse event/product quality complaints from customers in compliance with procedures and relevant regulations
  7. Prepare trend analysis reports of product quality complaints and initiate relevant actions.
  8. Ensure local execution align with Japanese regulations and J&J global standards
  9. Contribute to the BQ mission, vision and strategy
  10. Contribute to Quality deliverables for Japan
  11. Support GxP systems (CAPA, Change Control, Deviation, Training etc.)
  12. Contribute the GMP Intelligence Program to assess and monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.

Special requirements:
  1. +2 years of directly related experience in quality assurance and quality related activities.
  2. Demonstrated ability to manage relationship development and maintenance, and negotiation skills.
  3. Product lifecycle management experience (preferable: pharma)

Other features of the job:

Job location:
J&J Tokyo Head Office, Japan or
J&J Fuji Plant, Japan

Job Requirements

Essential knowledge and skills:

  1. Experience with Japanese pharmaceutical companies
  2. Good communication skills both in English and Japanese
  3. Good verbal and written communications skills. Must be able to articulate ideas with same levels of an organization.
  4. Knowledge in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
  5. Project management skill

Core competencies required for this role:

  1. Leadership as an individual contributor to challenge the status quo and how things have always been done.
  2. Motivation with high personal integrity and application of J&J Credo Values in daily operations.
  3. Leadership experience leading  projects, programs or other global initiatives
  4. Can show his/her agility, ability to learn fast and comfort in complex environment.
  5. Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders

Primary Location
Janssen Pharmaceutical K.K. (7195)
Job Function
Quality Assurance
Requisition ID