Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Quality Assurance Leader is responsible for leading 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 the QA process including Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, SOP and documentation management.
• Function as Hinseki to support the Sanyaku organization within the Japan office, with eventual progression to Sokatsu.
• Lead the preparation and execution of Quality Management Reviews for the region.
• Manage quality evaluation of warehouse operations, manufacturing sites, and external laboratories.
• Provide support to routine activities, projects, development and training relevant to area of expertise.
• Support continuous improvement activities regarding areas of responsibility.
• Support local business growth in line with global quality practices and local commercial priorities.
• Engage in assessment of regulatory impact on product and manufacturing processes.
• Analyze and communicate proposed, new or changing requirements and devise strategies for their implementation, ensuring business goals are met.
• Identify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisions.
• Engage in site inspections and prepare audit observations response as necessary.
• Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters.
• Support Global supplier quality audit activities.
• Work with local CMOs and global manufacturing to maintain continuous product quality excellence.
• Provide key quality support for regulatory product-specific inspections.
• Handle correspondence with PMDA and Tokyo Metropolitan Office Health Authority.

Requirements

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

Skills

• MS Office word processing
• MS Office spreadsheet
• MS Office presentation
• MS Office database applications
• eQMS systems
• eDMS systems
• TrackWise
• Veeva Vault
• ERP systems
• WMS systems
• SAP
• MS Teams
• Root cause analysis
• Problem solving
• Independent work
• Adaptability
• Cross-functional team collaboration
• Customer responsiveness
• Attention to detail
• Results-oriented
• Japanese communication
• English communication
• Managerial skills
• People guidance
• Project management
• Time management
• Analytical thinking
• Logical thinking
• Critical thinking
• Pharmacist (preferred)
• Hinseki roles
• Sokatsu roles
• People leading/managing
• MNC pharmaceutical/healthcare product organizations
• CA/PA systems
• GMP
• GDP
• GQP
• QC testing
• Technical transfer

Location

• Japan

Work Type

• Hybrid

Experience Level

• 7 years of experience in pharmaceutical and/or healthcare products industry or other regulated industry
• 3-5 years of QA experience in a pharmaceutical and/or healthcare products manufacturing environment and/or country office affiliate operations environment
• 3 years in a supervisory or managerial role

Education Level

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

Benefits

• Total rewards designed to unlock ambition
• Flexibility
• Salary and benefits expected from an organization with global strength and scale
• Career opportunities
• Culture that fosters care, collaboration and support

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.
• Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

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.