J&J Family of Companies [Janssen] Business Quality Specialist in Chiyoda, Japan
■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). Especially, the role will play a key role in maintaining consistency of manufacturing, product specifications and test methods with the registered dossiers in Japan and maintenance of SOPs in BQ aligned with global standards.
■Essential duties and responsibilities:
Responsibilities include, but not limited to:
Ensure consistency of the manufacturing, specifications and test methods with the registered dossiers in Japan. Maintain Quality Agreement with External Manufactures, Contract Laboratories and Logistic Service Providers as needed.
Or Handle product complaints from customers in compliance with the procedures and relevant regulations, including communication with the customers.
Lead corrective and preventive actions to maintain compliance status with the registered dossiers in Japan.
Ensure BQ operating procedures with J&J global standards
Contribute to the BQ mission, vision and strategy
Contribute to Quality deliverables for Japan product launches, lifecycle events and other commercialization activities
Support GxP system (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.
■Essential knowledge and skills:
Experience with Japanese pharmaceutical companies
Excellent communication skills both in English and Japanese
Strong verbal and written communications skills. Must be able to effectively 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 to challenge the status quo and how things have always been done.
Leadership and 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 even in a new work area.
Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with key stakeholders
+3 years of directly related experience in quality assurance and quality related activities.
Demonstrated ability to manage relationship development and maintenance and negotiation skills.
Product commercialization and lifecycle management experience (preferable: pharma)
Janssen Pharmaceutical K.K. (7195)