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.
Education and Qualification:
- Bachelors or Masters degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy.
- Pharmacist License.
- 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.
Johnson & Johnson KK (8235)
Johnson & Johnson