Quality Management Systems: Specialist ~ Senior Specialist

Quality Supervisor / Quality Assurance

Medical Products Industry (Global Manufacturer)

Role Overview

• Led the design, operation, and continuous improvement of a regulated Quality Management System (QMS) in Japan, ensuring compliance with local regulations and global quality standards.

• Acted as Subject Matter Expert (SME) for assigned quality system processes, collaborating with domestic and international stakeholders.

• Served as a regulatory liaison during government inspections and audits.

• Ensured product quality and safety as a market authorization holder, overseeing quality activities at domestic and overseas manufacturing sites.

Key Responsibilities

• Maintained and improved QMS compliance with Japanese regulations (e.g., GQP, QMS, GMP) and internal global standards.

• Led quality system process development, implementation, and optimization as SME.

• Defined and executed quality objectives and KPIs; planned actions and led team execution.

• Managed quality assurance activities for new product launches and product discontinuations.

• Served as Lead Auditor for internal and supplier audits.

• Evaluated and approved changes to manufacturing and testing processes impacting product quality.

• Controlled creation, revision, and maintenance of regulated documentation (product standards, quality manuals, risk management files, packaging and material specifications).

• Aligned local procedures with global requirements and ensured consistency.

• Directed and supported quality improvement initiatives at manufacturing partners.

• Supported product recalls and field corrective actions; coordinated execution and regulatory communications as required.

• Prepared for, supported, and led responses to regulatory inspections and internal/global audits.

• Drove internal quality awareness and compliance culture.

• Contributed broadly as a core member of the Quality Assurance team.

Experience & Education

• Experience in Quality Assurance or Quality Control within medical device, pharmaceutical, or related regulated industries.

• Knowledge of Japanese pharmaceutical and medical device regulations (GQP, QMS, GMP).

• Bachelor’s degree or higher in a science or engineering discipline preferred.

• Pharmacist license preferred.

• Business-level English proficiency (reading, writing, speaking).

• Strong proficiency with standard office software.

Skills & Competencies

• Quality Management Systems (QMS) leadership

• Regulatory compliance and audit leadership (Lead Auditor experience)

• Change control, risk assessment, and CAPA

• Cross-functional and global collaboration

• Strong communication and people leadership

• Process-oriented, detail-focused execution

• Proactive problem identification and resolution

• Continuous improvement mindset and results delivery