J&J Family of Companies [Janssen] Business Quality Group Manager in Chiyoda, Japan

■Overall purpose of job:

This role is responsible for

Overseeing performance and leadership in the Quality Assurance group under the Good Quality Practice (GQP) ordinance.

Business Quality Executive, who leads deployment of J&J quality standards in Janssen Japan and relevant discussion, and ensures Janssen high-quality products are available for Japanese market every day.

■Essential duties and responsibilities:

Develop the Quality Assurance group members so that they can achieve their goals and objectives well.

Provide overall direction to the Quality Assurance group members.

Provide an effective procedure and adequate resources to handle product and AE complaints, escalate critical product issues and conduct recalls and other field actions in a timely manner.

Collaborate effectively with various internal and external partners, such as the local Health Authorities, the LSO, the manufacturing plant QA, the logistic department and any other functions supporting complaint management.

Implement the J&J quality standards and relevant documents.

Ensure procedures of the Local Operating Company (LOC) are prepared, updated and approved in accordance with local regulations and J&J requirements.

Supporting the Quality Assurance Manager (品質保証責任者) under the Good Quality Practice (GQP) ordinance, ensure that quality control is performed for release on the market, efforts are made to collect quality information and appropriate measures are taken if quality is defective.

With the Quality Assurance Manager (品質保証責任者)…

Develop the tactical and operational plans for the Quality Assurance group and ensures that tactical objectives are met in support of strategic targets.

Ensure consistency between marketing approval documents, quality agreements, manufacturing practices and change control with the Quality Assurance Manager (品質保証責任者).

Ensure appropriate communication with foreign manufacturing sites

Ensure product complaints are handled in compliance with the procedures and relevant regulations. And if needed, manage escalation alerts.

Ensure appropriate internal and external change control systems are in place and are followed.

Ensure quality system performance versus local regulations and J&J requirements are monitored via use of pertinent business and compliance metrics and goals.

Drive continuous improvement in the Quality System using quality system performance information, in conjunction via periodic internal audits, deviation management, CAPA management and performance reviews.

Notify and engage Business Quality Head and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures.

Ensure suppliers of any critical materials (drug substances, excipients, printed packaging materials) used for local manufacturing (in-house or at external manufacturers) are qualified and periodically audited against company & local GMP standards.

Ensure a robust quality system is in place that describes the reception, quarantine, storage, release and distribution stages, which guarantees product quality, identity and traceability throughout the supply chain.

Ensure that all Marketing Authorizations / Product Licenses, Manufacturing / Packaging and / or Import Licenses are available and kept up to date for all marketed products.

Support the LOC management team in new product introduction and all other product portfolio lifecycle management processes.

Qualifications

■Essential knowledge and skills:

Knowledge of science and Japanese regulations applicable to biologics and/or pharmaceuticals

Excellent communication skills both in English and Japanese

Project management skill

Excellent interpersonal skills

■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

■Special requirements:

A minimum of 10 years’ experience within the biological and/or pharmaceutical industry, or Johnson & Johnson

Substantial experience as a line manager including professional development of his/her subordinates

And it is preferred

Have experience in manufacturing, product quality, CMC, RA or GXP audit

Have a pharmacist’s license

Primary Location

Japan-Tokyo-To-Chiyoda

Organization

Janssen Pharmaceutical K.K. (7195)

Job Function

Quality Assurance