Job offer: Director in Chiyoda with Johnson & Johnson


POSITION HPLC

The BQ Associate Director has the overall Quality oversight & responsibility to ensure Quality and Regulatory Compliance of all commercialized products in J & J Consumer Health Japan. The incumbent has roles of Japan BQ Lead and Quality Assurance Supervisor (HinSeki) for OTC, Quasi-Drug, Cosmetic and Class I Medical Device.

ROLE AND RESPONSIBILITY

  • Lead and manage for ensuring compliance to the applicable regulation (GQP and Medical Device QMS for Japan), J & J policies, standards & procedures.
  • Lead and manage end-to-end Franchise Quality under J & J Marketing Authorization and J & J Quality Management System (QMS).
  • Manage and report critical quality issues (J & J escalation and matter should be reported to General Marketing Supervisor) and execute immediate actions for risk mitigation.
  • Manage and execute GQP Quality Assurance Supervisor roles including product release, quality information management (product quality complaint), deviation and non-conformance handling, CAPA, change control, annual product review, Quality management review, GMP audit, quality metric review, qualification and oversight of manufacturer / supplier, etc.
  • Manage and be responsible for new product launch from Franchise quality.
  • Lead and execute continues improvement and maximize productivity of quality operations.
  • Manage and facilitate regulatory inspection and JJRC audit.
  • Contribute Quality intelligence program to assess and monitor Japanese regulation, standards and guidance document related to GxP, as well as Johnson & Johnson policy and standard.
  • Collaborate with Safety Management Supervisor (Local Safety Officer) for Japanese PMD Act requirements and report to General Marketing Supervisor.
  • Develop and lead a capable Japan BQ organization. Be responsible for budget, staffing, career planning, training and development and providing for a safe and pleasant working environment for Japan BQ.
  • Be the primary quality partner for Japan business / commercial organization and other cross-functional teams internally and externally.

Qualifications

Education and Qualification:

  • Bachelors or Masters degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy.
  • Pharmacist License.

Experience:

  •  Over 5 years of direct related experience in quality assurance, quality related operations and regulatory compliance in regulated Pharmaceutical / Medical Device industry.
  • Quality Assurance Supervisor experience in Pharmaceutical or Quasi-Drug if he / she is not Pharmacist
  • People management experience.
  • Regulatory inspection experience is desirable.

Other Preferred Competency and Skills:

  • Demonstrated ability to manage relationship development and maintenance and negotiation skills.
  • Comprehensive knowledge of Japanese regulations applicable to Drug, Quasi-drug and Cosmetics.
  • Written and verbal communication skills in English.

Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Johnson & Johnson KK (8235)
Job Function
Quality
Requisition ID
2005867670W

Johnson & Johnson



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