[Quality] Senior Manager/Director Commercial Quality [IM]

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
People Leader

All Job Posting Locations:
Chiyoda, Tokyo, Japan

Job Description:

Overall Purpose of the Role

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 (Marketing Authorization Holder) requirements.
The role safeguards business continuity, product quality, regulatory compliance, and patient safety.

When the candidate's qualification meets the requirement, the position also fulfills the full legal responsibilities of Marketing Supervisor General for pharmaceuticals (class I, II) and regenerative products, as defined under the PMD Act, ensuring market quality oversight and regulatory compliance.

Key Responsibilities:

1) Quality Management System (QMS) Governance


* Establish, maintain, and continually improve a compliant GQP‑aligned Quality Management System covering all post‑marketing activities.


* Ensure that internal and external manufacturing sites supplying Japan operate in compliance with GMP and GQP requirements.


* Ensure local processes are aligned with global and regional policies, standards, and governance requirements.


* Lead QMS performance management, including metrics, management reviews, and continuous improvement.

2) GxP Compliance and Regulatory Oversight


* Oversee local implementation of regulatory and corporate quality requirements across all GxP functions.


* Ensure timely monitoring and implementation of evolving regulatory expectations.


* Maintain readiness for internal audits and regulatory inspections.


* Represent Japan in regional and global quality initiatives.

Market Supervision Responsibilities (Marketing Supervisor General - PMD Act)
As the legally accountable Marketing Supervisor General, the role has end‑to‑end responsibility for market quality surveillance and post‑marketing compliance.

1) Market Quality Surveillance - Key Responsibilities


* Monitor quality and safety issues arising in the Japanese market and take timely and appropriate actions, in collaboration with the QA Manager (Hinseki) and Safety Manager (Anseki)


* Oversee complaint handling, post‑marketing quality investigations, and regulatory reporting requirements.


* Lead qualityâ...