Senior Manager/Director Commercial Quality

About the role

The Senior Manager/Director Commercial Quality serves as the Japan Quality Leader, overseeing post‑marketing GxP activities to ensure compliance with Japan Good Quality Practice, J&J global policies, and PMD Act requirements. This role safeguards product quality, regulatory compliance, and patient safety while leading a cross‑functional quality team.

Key responsibilities

• Establish, maintain, and improve a GQP‑aligned Quality Management System covering all post‑marketing activities.
• Oversee GxP compliance, regulatory oversight, internal audits, and inspections across all functions.
• Lead market quality surveillance, complaint handling, recalls, and field safety actions in Japan.
• Serve as the primary contact for regulatory bodies and ensure MAH‑required documentation is audit‑ready.
• Directly supervise the Quality Assurance Manager and develop talent across GxP teams.

Required profile

• Licensed Pharmacist (mandatory for Marketing Supervisor General under PMD Act).
• Minimum 10 years of quality management experience in pharma/biotech.
• Minimum 10 years of people leadership experience.
• Deep knowledge of GQP, GVP, and GMP requirements.
• Strong communication and influencing skills with senior leadership.

Required skills

• GQP (Good Quality Practice)
• GVP (Good Pharmacovigilance Practice)
• GMP (Good Manufacturing Practice)
• CAPA (Corrective and Preventive Action)
• ISO 9001
• Quality Management Systems (QMS)
• SOP (Standard Operating Procedure)