Associate Director, Quality Assurance

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Job details

Company overview

Our client is developing and providing various medicines for an array of health concerns.

Responsibilities

• The Commercial Quality Lead - Japan has the overall Quality oversight & responsibility to ensure Quality and Regulatory compliance of all Commercialized Products, Japan LOC , Consumer related Distribution Centers and Warehouses within Japan base business, ensuring all applicable regulations as well as Enterprise Quality Policy Standards and procedures . The incumbent is also responsible for end-to-end Franchise Quality under Marketing Authorization and Quality Management System (QMS).
• This position is also responsible for Quality Assurance Supervisor (QP) who is accountable for quality assurance of Marketing Authorization products and reports to General Marketing Supervisor (SoSeki) in good collaboration with Safety Management Supervisor (AnSeki).

Requirements

Education and Qualification:

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

Experience:

• Over 10 years of direct related experience in quality assurance, quality related operations and regulatory compliance in regulated Pharmaceutical industry.
• Quality Assurance Supervisor experience in Pharmaceutical or Quasi-Drug if he/she is not Pharmacist
• People management experience.
• Regulatory inspection experience.

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.
• 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.

Salary

6 - 10 million yen

Location

Tokyo