Johnson & Johnson Careers

【Janssen】Business Quality Product Quality Complaints Sr Specialist

Chiyoda, Japan
Quality Assurance

Job Description

Requisition ID: 1805688027W

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:
  • 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.
  • Manage product quality complaints intake process and Trackwise records until completion.
  • Lead development of communication with the customers.
  • Work with Medical Representatives in appropriate communication with customers.
  • Review acceptability of complaints investigation reports to closure.
  • Work with Pharmacovigilance on combined adverse event/product quality complaints from customers in compliance with procedures and relevant regulations
  • Prepare trend analysis reports of product quality complaints and initiate relevant actions.
  • Ensure local execution align with Japanese regulations and J&J global standards
  • Contribute to the BQ mission, vision and strategy
  • Contribute to Quality deliverables for Japan
  • Support GxP systems (CAPA, Change Control, Deviation, Training etc.)
  • 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:
  • +2 years of directly related experience in quality assurance and quality related activities.
  • Demonstrated ability to manage relationship development and maintenance, and negotiation skills.
  • Product lifecycle management experience (preferable: pharma)

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

Job Requirements

Essential knowledge and skills:

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

Core competencies required for this role:

  • Leadership as an individual contributor to challenge the status quo and how things have always been done.
  • Motivation with high personal integrity and application of J&J Credo Values in daily operations.
  • Leadership experience leading  projects, programs or other global initiatives
  • Can show his/her agility, ability to learn fast and comfort in complex environment.
  • 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