QA associate Director, Pharmaceutical , Tokyo ,17M JPY
Tokyo 23 Wards
¥12,500,000 - ¥17,000,000
Working closely with Professional team in the market
Rewarding and Challenging tasks will be provided
About Our Client
- Global life science based company, provides many products to consumers for many years.
- Lead and manage for ensuring compliance to the applicable regulation (GQP and Medical Device QMS for Japan), company policies, standards & procedures.
- Lead and manage end-to-end Franchise Quality under company Marketing Authorization and company Quality Management System (QMS).
- Manage and report critical quality issues (company 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.
- Be the primary quality partner for Japan business / commercial organization and other cross-functional teams internally and externally.
The Successful Applicant
- Bachelors or Masters degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy.
- Pharmacist License.
- Good experiences 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.
- 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.
What's on Offer