Senior QA Manager

Job Title: Senior QA Manager

Location: Tokyo

About Us: Our client is a global leader in the development, supply, and support of specialty excipients and fully formulated products for the pharmaceutical and nutritional industries. They have established a strong reputation for providing high-quality products and exceptional technical support services that aid in the design, development, and manufacture of solid oral dosage forms.

Key Responsibilities:

• Maintain and improve the site Quality Management System (QMS) effectiveness and compliance with global and local regulatory (ie Japan Pharmaceutical Affairs Law) requirements.
• Management of external and internal audits or inspections program to ensure its effectiveness.
• Maintain and improve the site training and education program ie by ensuring an efficient Learning Management Systems (LMS) and meet applicable standards/requirements
• Ensure compliance of Waters Japan products and processes with the Quality Agreement between Waters Japan and legal manufacturers.
• Routinely perform compliance assessments on processes, procedures and regulations to identify potential gaps and implement improvements.

Qualifications:

• Minimum 10 years of experience in the commercial medical device, diagnostic products or pharmaceutical industry of which minimum 5years in managerial position.
• Proven experience in supporting or leading third party audits (ISO registrars, PMDA or other regulatory authorities).
• Minimum 5years of QMS Lead Auditor experience.
• Good understanding of PMD Act, relevant regulations and guidelines.
• To apply, click on the apply button or reach out to Ke Xuan.

EA License No: R23116252