The BQ Specialist is responsible for Dr.Ci:Labo (DCL) quality operation in J&J Consumer Health Japan as primary role. This includes both Quality Management System (QMS) and Product (Franchise) Quality for ensuring compliance to the applicable regulation (GQP/GMP/QMS and/or Food regulation) and J&J policy, standard & procedures.
The incumbent will report either Manager/Associate Director in J&J Japan LOC or DCL LOC.
This position will manage OTC GQP or Food Quality Assurance as secondary role.
The incumbent is a potential successor of GMP Pharmacist or GQP Quality Assurance Supervisor for OTC, etc.
Job Description – Basic Role and Responsibility
Manage DCL QMS establishment projects, Product compliance review, J&J system integration, talent capability building, etc.
Manage Good Distribution Practice (GDP) in the market specially for drug (OTC) product.
Implements new product launch readiness including quality deliverables and GMP inspection (paper and on-site).
Maintains J&J Quality Policy and Standards aligned with GQP and Pharmaceutical and Medical Devise Act (PMD Act) - products may include OTC, Quasi-Drug, Cosmetic, Type I Medical Device and Food.
Maintain Quality Assurance of Food with local Food regulation.
Contributes to the J&J mission, vision and strategy.
Implements GxP system based on J&J Standard and GQP, such as Batch Release, Change control, Deviation and Non-conformance (NC), CAPA, GMP Audit, Supplier Qualification, Self-inspection, Training, Product Quality Complaint, Recall, etc to maintain Quality and Regulatory compliance.
Maintain good relationship with cross-functional team and manage resolution program for product quality issues.
Implements J&J APAC BQ projects, such as Operational Excellence, LCM, and other commercialization activities, etc.
Supports regulatory Inspections and inspection readiness.
Monitor Japanese regulations, standards and guidance documents related to GxP, product testing and Japanese Pharmacopoeia requirements.
Education and Qualification:
Doctorate/Masters +1, Bachelors +3 years of directly related experience in quality assurance and quality related activities.
Pharmacist license or Food quality experience is mandatory.
Regulatory inspection experience is desirable.
Experience in Japan with multiple language capability (English, Japanese)
Must have demonstrated interpersonal skills, including temperament, objectivity and approach that will facilitate effective interactions with a team of seconded staff.
Ability for travel to international destinations as needed.
Other Preferred Competency and Skills:
Demonstrated ability to manage relationship development and maintenance.
Comprehensive knowledge of Japanese regulations applicable to Drug, Quasi-drug and Cosmetics.
Good communication capability to facilitate effective interaction and motivate the team members.
Self leadership and motivation with high personal integrity and application of Johnson & Johnson value.
Experience performing GMP audits.
Primary Location Japan-Tokyo-To-Chiyoda-
Organization Johnson & Johnson K.K. (8235)
Job Function Quality
Requisition ID 2105899289W