QA Associate Director [GQP]

---

Job details

Company overview

We are a leading life sciences company based in the United States, with a parent company. Our core business revolves around the research, development, importation, manufacturing, and sale of pharmaceuticals and vaccines. Every day, we strive towards our mission and goals by protecting people's health and helping them build fulfilling lives. We aim to promptly address unmet medical needs in Japan and globally. Furthermore, we actively engage in activities to promote access to medicines, including product donations and supply to those in need through various programs and partnerships.

Responsibilities

This position will be responsible for the General Manufacturing and Sales Manager under the Pharmaceuticals and Medical Devices Act and the Quality Assurance Manager under the GQP Ministerial Ordinance.
Main responsibilities:

• You will be responsible for quality assurance on our leadership team and will work with the Pharmaceutical Safety Manager to ensure ongoing compliance by making recommendations regarding product safety.
• Based on collated batch records and QC test data conducted in Japan , you will be responsible for continuously monitoring the quality of products imported to Japan and products supplied by contract manufacturers in Japan, and will be responsible for managing the products to ensure their safe shipment.
• You will report safety and quality issues and emergencies to the relevant government agencies in a timely manner.

Requirements

Minimum requirements:

• Bachelor's degree in pharmacy, pharmacist license.
• Native level Japanese, English skills required (reading, writing, speaking)
• Extensive knowledge and experience in GMP and regulatory requirements, expertise and extensive experience in quality systems, quality assurance and quality control
• Strong problem-solving skills and risk management capabilities based on understanding science, data, and regulatory requirements in an evolving environment.
• Expertise in pharmacology, analytical chemistry, microbiology, aseptic processing, cGMP, regulatory affairs, etc.
• Vaccine manufacturing and testing experience
• Ability to demonstrate interpersonal, communication, negotiation, persuasion and leadership skills in a diverse cultural setting, and ability to deal with organizational complexity and ambiguity.
• Exemplary people/team leadership experience including leading and motivating a team.
• Experience establishing performance metrics and holding people accountable for results.
• Experience and problem solving skills in vaccine QC

Salary

18 - 20 million yen

Location

Tokyo