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.

Qualifications

■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

■Special requirements:

+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)

Primary Location

Japan-Tokyo-To-Chiyoda

Organization

Janssen Pharmaceutical K.K. (7195)

Job Function

Quality Assurance