Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Essential Duties and Responsibilities

Plan and drive overall quality assurance, manufacturing control, and safety management activities for handled products and services in compliance with QMS, GVP, and the Pharmaceuticals and Medical Devices Act (PMD Act).

Scope of Products:

• In vitro diagnostics, medical devices, research-use products, and consumables imported and distributed by Thermo Fisher Diagnostics K.K. (TFD)
• Product portfolio includes allergy-related products, autoimmune disease products, protein diagnostics, biomarker-related products, quality control materials, and microbiological testing products

1. Key Responsibilities:

• Based on business plans, anticipate and evaluate risks associated with new products and services, establish procedures, and ensure proper documentation and record retention to guarantee safety and compliance with Japanese regulations
• Foster a quality culture by ensuring processes for the creation and maintenance of QMS and GVP-related documents and records are established and compliant with applicable requirements
• Oversee and supervise domestic manufacturing sites and laboratories to ensure appropriate quality and manufacturing control; maintain timely and effective communication with overseas manufacturing sites
• Communicate effectively with internal and external stakeholders (domestic and international), collect quality-related information, ensure timely issue resolution, and propose/implement or support risk-based CAPA (Corrective and Preventive Actions)
• Ensure proper execution of product recalls, adverse event reporting, and foreign regulatory actions by liaising with regulatory authorities (MHLW, PMDA, and local prefectural governments), based on sufficient knowledge of QMS, PMD Act, and internal processes
• Ensure appropriate execution of internal and external audits in accordance with applicable standards and promote continuous improvement of the QMS
• Coach team members and provide training and communication to employees to enhance organization-wide understanding and compliance with QMS
• Monitor regulatory changes and proactively plan and implement actions in anticipation of future trends

2. Required Skills and Qualifications:

• Strong communication skills to effectively collaborate with colleagues in Japan and globally
• Ability to plan and prioritize multiple tasks and activities efficiently
• Knowledge of QMS, GVP, and the PMD Act
• Proficiency in English (reading, writing, and communication with global stakeholders)
• Ability to appropriately assess risks and develop mitigation measures
• Ability to accurately understand situations and make evidence-based decisions
• Strong planning, coordination, and execution skills to lead cross-functional initiatives