Designs and improves Global IT performance management, defines KPIs, monitors results, reports to leaders, identifies gaps, and supports efficiency, goal-setting, and budget activities.
About this role
The QMS Manager/Engineer maintains, improves, and harmonizes Quality Management Systems across regional and global operations. The role serves as the primary Quality lead for an enterprise-wide ERP transformation and works with IT, Supply Chain, Manufacturing, Engineering, Regulatory, and Quality teams.
As ERP Quality Management Process Owner, the role maps, validates, and integrates nonconformance, CAPA, audit, change-control, and document-control processes into the ERP platform. Responsibilities include translating QMS requirements into ERP functional specifications, supporting User Requirement Specifications, design reviews, validation protocols, and user acceptance testing, and ensuring that ERP configuration aligns with global QMS policies, regulatory requirements, and industry standards. The role also identifies risks related to system migration, master data, document migration, and process harmonization; supports global training development; and delivers training when required.
The position maintains QMS processes, procedures, and documentation; reviews or owns process changes; harmonizes legacy and site-specific processes into a standardized global model; supports adoption at regional sites; and helps close compliance gaps found through audits or process reviews. It supports internal and external audits as a subject matter expert and ensures ERP-related changes are validated and documented under GxP/GMP requirements.
The role identifies process improvements, uses ERP and QMS data to monitor performance, trends, and compliance metrics, collaborates with Quality Leaders at global, regional, and site levels, reports implementation progress and risks to senior leadership, and facilitates cross-functional workshops.
A bachelor’s degree in engineering, life sciences, Quality, or a related field is required. Candidates need 5–10+ years of QMS experience in manufacturing, medical devices, pharmaceuticals, biotech, industrials, or similar regulated environments. Required experience includes QMS processes such as CAPA, NCR, audits, document control, change control, training, and complaints; ERP Quality modules such as SAP, Oracle, Microsoft Dynamics, or Infor; and regulated system validation involving CSV, GxP, or Part 11. Strong cross-functional leadership, communication, analytical, project management, stakeholder management, adaptability, attention to detail, and compliance skills are required. English and Japanese fluency, availability for global working hours with a heavy JST focus, and international travel as needed are also required. Global multi-site QMS experience, ASQ or ISO auditor certifications, global QMS implementation experience, and Lean or Six Sigma certification are preferred.
This is a regular full-time position with a three-month probationary period and no change to terms during probation. Working hours are 8:45–17:30 with a 45-minute break and eight standard working hours. Flextime without core hours, reduced-hours work, telework, and overtime work are available, subject to applicable conditions. The position is based at the Global Headquarters in Hachioji, Tokyo, or the Shinjuku Satellite Office, with possible work at home, the Utsugi business site, or shared offices. Annual holidays total 129 days, and 20 days of paid leave are granted. Commuting and work-from-home allowances, social insurance, and defined benefit and defined contribution corporate pensions are provided.
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