Job Title: Quality Manager
Location: Tokyo, Japan
Job Summary: Our client is seeking an experienced and dedicated Quality Manager to join their dynamic team in an innovative global biotechnology company. The Quality Manager will be responsible for overseeing all aspects of quality assurance and control, ensuring compliance with regulatory standards, and maintaining the highest quality of our biotech products.
Key Responsibilities:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with GMP, GQP, and other relevant regulations.
- Lead quality assurance activities including product release, inspection, change control, and deviation management.
- Manage quality agreements with suppliers and handle quality complaints, executing quality improvement programs.
- Oversee document control and management of Standard Operating Procedures (SOPs) and related documents.
- Ensure compliance with PMDA and other regulatory requirements, including handling inspections and audits.
- Investigate causes of quality defects and implement corrective and preventive actions (CAPAs).
- Provide training and support to QA team members and conduct internal quality audits.
- Collaborate with global teams to align quality standards and practices.
Qualifications:
- Bachelor's degree in a scientific discipline; advanced degree preferred.
- Minimum of 7 years of experience in quality assurance within the pharmaceutical or biotech industry.
- In-depth knowledge of GMP, GQP, and regulatory requirements.
- Strong problem-solving skills and attention to detail.
- Excellent communication and leadership abilities.
- Proficiency in both Japanese and English.
