Johnson & Johnson Careers
【Janssen】Product Quality Complaints Senior Specialist
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.
- +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)
J&J Tokyo Head Office, Japan or
J&J Fuji Plant, Japan
with Japanese pharmaceutical companies
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.
in basic pharmaceutical laws and GxPs such as GMP, GQP, GDP, GLP, GCP etc
required for this role:
- Leadership as an
individual contributor to challenge the status quo and how things have
always been done.
with high personal integrity and application of J&J
Values in daily operations.
experience leading projects, programs
or other global initiatives
show his/her agility, ability to learn fast and comfort in complex
- Must have
demonstrated interpersonal skills, including temperament, objectivity and
approach that will facilitate effective interactions with key
Janssen Pharmaceutical K.K. (7195)Job Function
Quality AssuranceRequisition ID