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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 quality‑related decisions for recalls, product holds, and field safety actions.
• Ensure proper oversight of distribution and storage quality for Japan commercial operations.

2) MAH and Regulatory Accountability

• Ensure compliance with all legal obligations under the PMD Act related to product quality, safety, and documentation.
• Serve as the primary contact for regulatory bodies on post‑marketing quality matters.
• Ensure that MAH-required records and documentation are accurate, complete, and audit-ready.

3) Governance and Escalation

• Lead market risk assessments and escalate significant market quality issues to senior leadership.
• Ensure transparent communication and effective decision-making for issues impacting patient safety, product integrity, or market supply.

4) Leadership and Cross-Functional Responsibilities

• Directly supervise and develop the Quality Assurance Manager (Hinseki).
• Ensure adequate resourcing, capability, and training across all GxP teams.
• Provide strong cross‑functional alignment with Supply Chain, Deliver, Medical, Regulatory, Pharmacovigilance/ Safety and Commercial teams.
• Develop robust talent succession plan of Soseki role in the organization.
• Represent quality perspectives in business strategy, product planning, and operations.

Required Qualifications

• Licensed Pharmacist (mandatory requirement for Marketing Supervisor General under PMD Act.
• Minimum 10 years of Quality Management experience in pharmaceutical or biotechnology industry.
• Minimum 10 years of people leadership experience.
• Deep knowledge of GQP, GVP, and GMP requirements.
• Strong communication skills and capability to influence senior leadership.
• Experience representing quality in executive forums and strategic discussions.

Additional Notes

• This role is critical for regulatory compliance, patient safety, and business continuity.
• Responsibilities may be adjusted based on evolving regulatory or business requirements.

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Preferred Skills: