[quality] Senior Manager/director Commercial Quality [im]

Johnson & Johnson UK

Chiyoda, Tokyo, Japan
Gqp, gvp, and gmp requirements
Quality management system (qms) governance
Post-marketing gxp activities
The Senior Manager / Director of Commercial Quality serves as the Japan Quality Leader, responsible for ensuring that post-marketing GxP activities are executed in accordance with Japan Good Quality Practice (GQP), J&J global quality policies, and MAH requirements

Job Summary

  • The Senior Manager / Director of Commercial Quality serves as the Japan Quality Leader, responsible for ensuring that post-marketing GxP activities are executed in accordance with Japan Good Quality Practice (GQP), J&J global quality policies, and MAH requirements.
  • The role safeguards business continuity, product quality, regulatory compliance, and patient safety, and may fulfill legal responsibilities of Marketing Supervisor General for pharmaceuticals.
  • Key responsibilities include QMS governance, GxP compliance and regulatory oversight, market quality surveillance, MAH and regulatory accountability, and leadership across various functions.

Matching Summary

The Senior Manager / Director of Commercial Quality serves as the Japan Quality Leader, responsible for ensuring that post-marketing GxP activities are executed in accordance with Japan Good Quality Practice (GQP), J&J global quality policies, and MAH requirements.

Skills & Requirements

Must-have

  • GQP, GVP, and GMP requirements
  • Quality Management System (QMS) governance
  • post-marketing GxP activities
  • MAH (Marketing Authorization Holder) requirements
  • market quality surveillance
  • regulatory compliance

Nice-to-have

  • cross-functional alignment
  • talent succession planning
  • influencing senior leadership
  • business strategy representation

Key Requirements

  • Licensed Pharmacist
  • Minimum 10 years of Quality Management experience
  • Minimum 10 years of people leadership experience

Work Rights

Not specified

Tailored Resume

Cover Letter