Job Description

Company Overview
Quality Assurance Manager - Industry Leader Global Pharma Company

Job Description
Reporting directly to the Director of Quality Assurance, QA Manager will be responsible for monitoring the compliance with GQP Ordinance. Responsibilities include supporting to global Quality Management System. The role requires an individual who is able to work collaboratively across various expertise areas and is able to communicate effectively in a fast-paced environment.

Summary of Key Responsibilities

- Responsible for all QA related activities to ensure company compliance with Japanese regulations
- Maintain SOPs compliant with GQP/QMS requirements.
- Manage the global/local CMOs for drug manufacturing
- Lead operating the Quality Sub-systems process, e.g., change control, deviation control including CAPA, release disposition, training, self audit, and document control.
- Communicate well and collaborate effectively with company Quality groups worldwide
- Participate in academic and/or industrial associations for the advancement of Pharmaceutical Quality


- University degree, Pharmacist, PhD, or other advanced degree a plus
- 5+ years’ experience in a supervisory position in Quality Assurance (GQP) in a Japanese-located pharmaceutical or biotechnology company (either Japanese or foreign)
- 10+ years Quality experience
- Experience as a member of a multinational biotechnology or pharmaceutical company in Japan a strong plus
- Experience with Specialty Pharmaceuticals,
- Current participation in academic or industrial professional associations in Quality
- Good writing, reading, and speaking ability in English
- Good communication skills including writing and preparing presentations in Japanese and English
- Experience in interacting with regulatory authorities in Japan including GQP/GMP PMDA Inspection
- Experience with writing and implementing company SOPs in Japan
- Experience with writing and maintaining the Quality Agreement and Quality Mater File, and
- Experience in interacting with the GMP facility to keep in compliance with Japan regulations

Additional Job Information
Successful candidate must:

- Be scientific and logical thinking mind set
- Be comfortable in a multi-cultural environment
- Be enthusiastic about playing a key role in helping to have the company in compliance status with GQP
- Be able to travel to outside Japan as well as domestic destination for troubleshooting