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About the Role

Lead the Quality Assurance function in Japan, ensuring compliance with current regulations (GQP ministry ordinance) and PDx GDP/GMP QA regulations to support continuous business and organizational growth.

Responsibilities

• Own QA processes including Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, and SOP/documentation management.
• Function as Hinseki to support the Sanyaku organization in Japan, with potential progression to Sokatsu.
• Lead preparation and execution of regional Quality Management Reviews.
• Manage quality evaluation of warehouse operations, manufacturing sites, and external laboratories.
• Provide support for routine activities, projects, development, and training within the area of expertise.
• Support continuous improvement activities for areas of responsibility.
• Support local business growth aligned with global quality practices and local commercial priorities.
• Assess regulatory impact on product and manufacturing processes.
• Analyze and communicate new or changing regulatory requirements, devising implementation strategies and liaising with GEHC functions, industry bodies, or regulators.
• Proactively identify, assess, and manage regulatory risk, providing data for senior management decisions.
• Engage in site inspections and prepare responses to audit observations.
• Own compliance assessment and remediation plans, influencing execution, communications, and training for Quality matters.
• Support global supplier quality audit activities.
• Collaborate with local CMOs and global manufacturing to maintain continuous product quality excellence.
• Provide key quality support for regulatory product-specific inspections.
• Correspond with PMDA and Tokyo Metropolitan Office Health Authority.
• Comply with GEHC Quality Manual, Quality Management System, Policy, Goals, and applicable regulations (GQP ministry ordinance).
• Complete all planned Quality & Compliance training on time.
• Identify and report quality or compliance concerns, taking immediate corrective action.
• Ensure on-time reporting of metrics for quality management reviews.

Requirements

• B.S. Degree in bioscience, chemistry, pharmaceutical, or technical field.
• At least 7 years of experience in pharmaceutical, healthcare products, or other regulated industries.
• At least 3-5 years of QA experience in pharmaceutical/healthcare products manufacturing or country office affiliate operations, with at least 3 years in a supervisory or managerial role.
• Proficiency with MS Office applications (word processing, spreadsheet, presentation, database).
• Proficiency with eQMS and eDMS systems (e.g., TrackWise, Veeva Vault).
• Proficiency with ERP/WMS systems (e.g., SAP).
• Proficiency with teleconferencing software platforms (e.g., MS Teams).
• Ability to identify root causes and creatively problem-solve for resolution.
• Ability to work independently in a fast-paced environment with minimal supervision.
• Ability to adapt to constant change and effectively influence positive change.
• Team-oriented, with experience working with local and global cross-functional teams and responsiveness to customer needs.
• Quality-focused, attentive to detail, and results-oriented.
• Effective communication skills in Japanese and business-level English (written and oral).
• Strong managerial, people guidance, project management, and time-management skills.
• Strong analytical, logical, and critical thinking skills.

Skills

• Pharmacist (preferred for Hinseki, mandatory for Sokatsu track).
• Experience in Hinseki and/or Sokatsu roles.
• People leadership/management experience.
• Working experience in MNC pharmaceutical/healthcare product organizations.
• Experience with CA/PA systems (GEHC electronic QA system).
• Experience applying GMP, GDP, and GQP regulations.
• QC testing experience for sterile products.
• Technical transfer experience for QC test or manufacturing process for sterile products.

Location

• Japan
• Hybrid

Work Type

• Hybrid

Experience Level

• At least 7 years of experience.
• At least 3-5 years of QA experience.
• At least 3 years in a supervisory or managerial role.

Education Level

• B.S. Degree in bioscience, chemistry, pharmaceutical, or technical field.

About the Company

• GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits, fostering an environment where every voice makes a difference and builds a healthier world.
• Employees are expected to act with humility, build trust, lead with transparency, deliver with focus, and drive ownership with unyielding integrity.
• Total rewards are designed to unlock ambition, providing the boost and flexibility to turn ideas into world-changing realities. The organization offers career opportunities in a culture fostering care, collaboration, and support.

Equal Opportunity

• GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.