Requisition ID: 1805688027W
Overall purpose of
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 include, but not
- 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.
product quality complaints intake process and Trackwise records until
development of communication with the customers.
with Medical Representatives in appropriate communication with customers.
- Review acceptability of
complaints investigation reports to closure.
with Pharmacovigilance on combined adverse event/product quality complaints
from customers in compliance with procedures and relevant regulations
trend analysis reports of product quality complaints and initiate relevant
- 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
ability to manage relationship development and maintenance, and negotiation
lifecycle management experience (preferable: pharma)
J&J Tokyo Head Office, Japan or
J&J Fuji Plant, Japan
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
Janssen Pharmaceutical K.K. (7195)ジョブ
Quality AssuranceRequisition ID