品質保証部長/ Director QA

A global biopharmaceutical company is looking for a Director QA. The selected candidate will oversee GMP/GQP/GxP systems, audits, batch disposition, and inspection readiness while driving continuous quality improvement.

Responsibilities:

• Lead QA strategy for product launches and MAH activities ensuring compliance with Japanese regulations
• Qualify and oversee importers, manufacturers, suppliers, and third-party partners
• Establish and maintain GMP, GQP, GDP, and controlled quality documentation
• Plan and manage internal and external GMP/GxP audits and follow up on findings
• Review and approve batch records, deviations, and quality data for batch disposition
• Act as primary QA contact for inspections, deviations, CAPAs, change controls, and complaints

Requirements:

• Bachelor’s degree or above in pharmaceutical life sciences (Pharmacy, Chemistry, Biotechnology etc.)
• More than 10 years of relevant experience in the pharmaceutical industry
• Experience in clinical and commercial phases of pharmaceuticals
• Prior experience in performing Audits, Risk Mitigation Plans and QA-driven projects from initiation to completion
• Background in the preparation and hosting of competent authority inspections
• Understanding of current Good Manufacturing, Good Quality, and Good Industry Practices in Japan
• Fluent level English and Japanese

Preferred requirement:

• Knowledge of peptides

About the Company:

A global biopharmaceutical company dedicated to improving lives through innovative medicines and meaningful support. Guided by collaboration and a commitment to excellence, the company works to address unmet needs and create lasting impact for patients, families, and healthcare providers.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: P3B073