Quality Specialist ~ Senior Specialist

Confidential Role: Quality Assurance Manager (Medical Devices / Pharmaceuticals)

Location: Tokyo, Japan
Category: Quality | People Leadership

Overview

A global healthcare company is seeking an experienced Quality Assurance Manager to lead and strengthen its Quality Management System (QMS) operations in Japan. The role will focus on ensuring compliance with domestic regulations and corporate quality standards, while driving continuous improvement across manufacturing, supply chain, and quality processes.

The position requires close collaboration with global and local stakeholders, oversight of regulatory inspections, and leadership in maintaining the highest standards of product quality, safety, and compliance.

Key Responsibilities

• Lead the establishment, maintenance, and continuous improvement of the company’s Quality Management System (QMS) in compliance with Japanese and global regulations.

• Serve as the Subject Matter Expert (SME) for assigned quality system processes and provide guidance across cross-functional teams.

• Manage quality assurance activities related to new product launches, product discontinuations, and ongoing commercial operations.

• Lead internal and supplier audits as a qualified lead auditor; oversee audit preparation and follow-up for regulatory and corporate inspections.

• Oversee change management related to manufacturing or testing processes that may impact product quality.

• Ensure timely execution of quality-related actions, including recall coordination, authority reporting, and regulatory communication.

• Develop, revise, and maintain key quality and risk management documentation in alignment with corporate and regional procedures.

• Promote quality culture and compliance awareness throughout the organization.

• Provide leadership and coaching to team members, fostering professional growth and accountability.

Qualifications & Experience

• Bachelor’s degree or higher in a scientific or engineering field (e.g., chemistry, biology, pharmacy, or related discipline).

• Proven experience in Quality Assurance or Quality Control within the medical device, pharmaceutical, or healthcare product industry.

• In-depth knowledge of Japanese quality and regulatory requirements (GQP, QMS, GMP, and related laws).

• Experience leading audits and interacting with regulatory authorities is preferred.

• Strong communication, leadership, and problem-solving skills.

• Business-level English proficiency (TOEIC 600+ or equivalent).

• Proficient in Microsoft Office and general quality management systems or ERP tools.

Core Competencies

• Strategic Vision: Understand emerging trends and apply new processes to business needs.

• Proactive Thinking: Identify potential issues early and develop effective countermeasures.

• Innovation: Encourage diverse perspectives and generate creative, compliant solutions.

• Leadership & Development: Support team growth and provide constructive feedback to enhance performance.

• Execution Excellence: Deliver results with a balance of speed, quality, and compliance focus.