Job Description SummaryDevelop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.

The Quality Assurance Leader is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance) with regards to the area of responsibility and specialization in support of continuous business and organizational growth.

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.

Job Description

Roles and Responsibilities

Business Process Management Systems (e.g. Quality Management Systems, Integrated Management Systems). Work to develop, implement, and monitor overall process mapping for quality improvement purposes. Standardization of processes, tools and performance management system.Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.

Essential Responsibilities

Own the QA process under, e.g., Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or 3PLs, APR/PQR, Stability Data Review, Validation, Change Control Management, Training, Distribution, etc.Function as Hinseki to support the Sanyaku organization within the Japan officeLead the preparation and execution of Quality Management Reviews for the regionManage quality evaluation of warehouse operations, manufacturing sites, and external laboratoriesProvide support to routine activities, projects, development and training relevant to area of expertise where requiredSupport continuous improvement activities regarding areas of responsibilityEngaging assessment regulatory impact on product and manufacturing processes.Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met. Includes liaison with other GE functions, industry bodies or regulators as requiredIdentify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisionsEngaging site inspections, preparing audits observations response as necessaryOwn compliance assessment and remediation plans while influencing execution, communications and training for Quality matters

Quality Specific Goals

Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals , and applicable laws and regulations (GQP ministry ordinance) as they apply to this job type/position Complete all planned Quality & Compliance training within the defined deadlines Identify and report any quality or compliance concerns and take immediate corrective action as required Ensure on-time reporting of the metrics for quality management reviews

Required Qualifications

For roles outside of the USA- This role requires advanced experience in the Quality & Business Process Management. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).For roles in USA - Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).B.S. Degree in bioscience, chemistry, pharmaceutical, business or technical field7 years experiences in medical device, pharmaceutical industry or other regulated industryAt least 3-5 years of QA experience in a pharmaceutical and/or medical device manufacturing environment (at least 2 years in a supervisory or managerial role)Proficient with MS Office word processing, spreadsheet, presentation, and database applicationsProficient with eQMS and eDMS systemsProficient with teleconferencing software platforms (MS Teams)Ability to identify root cause of problem and creatively problem solve to gain resolutionAbility to work independently in fast-paced environment with little supervision.Ability to adapt to constant change and influence positive change effectivelyTeam-oriented, with experience in work with cross-functional teams across local and global scope and responsive to customer needsQuality-focused, attentive to detail and results-orientedAbility to communicate effectively in Japanese and basic level of English (both written and oral)Strong managerial, people guidance, project management and time-management skills

Role Summary/Purpose

The Quality Assurance Leader (Hinseki) is responsible for leading the Quality Assurance function in Japan to ensure compliance with current regulations (GQP ministry ordinance) and PDx GDP/GMP QA regulations with regards to the area of responsibility and specialization in support of continuous business and organizational growth.,

Essential Responsibilities

Own the QA process under, e.g., 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, etc.Function as Hinseki to support the Sanyaku organization within the Japan office, with eventual progression to SokatsuLead the preparation and execution of Quality Management Reviews for the regionManage quality evaluation of warehouse operations, manufacturing sites, and external laboratoriesProvide support to routine activities, projects, development and training relevant to area of expertise where requiredSupport continuous improvement activities regarding areas of responsibilitySupport local business growth in line with global quality practices and local commercial prioritiesEngaging assessment regulatory impact on product and manufacturing processes.Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met. Includes liaison with other GEHC functions, industry bodies or regulators as requiredIdentify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisionsEngaging site inspections, preparing audits observations response as necessaryOwn compliance assessment and remediation plans while influencing execution, communications and training for Quality mattersSupport Global supplier quality audit activitiesWorking with local CMOs and global manufacturing to maintain continuous product quality excellenceKey quality support for regulatory product-specific inspectionsCorrespondence with PMDA and Tokyo Metropolitan Office Health Authority

Quality Specific Goals

- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals , and applicable laws and regulations (GQP ministry ordinance) as they apply to this job type/position

- Complete all planned Quality & Compliance training within the defined deadlines

- Identify and report any quality or compliance concerns and take immediate corrective action as required

- Ensure on-time reporting of the metrics for quality management reviews.

Qualifications/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

Desired Characteristics

- Pharmacist (preferred but not mandatory for Hinseki track, mandatory for Sokatsu track)

- Experience being in Hinseki and/or Sokatsu roles

- People leading/managing experience

- Working experience in MNC pharmaceutical/healthcare product organizations

- Experiences with CA/PA systems (GEHC electronic QA system)

- Experiences applying regulations (GMP, GDP, GQP)

- QC testing experience for sterile products

- Technical transfer experience for QC test or manufacturing process for sterile products

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.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No