Quality Assurance Leader (Hinseki)

Job Description Summary

本ポジションでは、社内外の要求事項を確実に満たすためのシステム・ルール・プロセスの構築および維持に携わっていただきます。また、プロジェクトや製品が適切に機能し、規定された品質基準を満たす状態を予防的な観点から確保することが求められます。

業務にあたっては、ベストプラクティスを踏まえながら、ご担当領域が他部門とどのように連携するのかを理解し、組織全体を見据えた推進力を発揮していただきます。さらに、市場における競合状況や自社の差別化要因にも目を向け、ビジネス視点を持って取り組んでいただきます。

日本における品質保証リーダーとして、品質保証機能全体を統括し、担当領域および専門分野において現行規制（GQP省令）の遵守をリードしていただく重要な役割です。これらを通じて、継続的な事業成長および組織強化に貢献いただきます。

役割概要 / 目的
品質保証リーダー（品責）として、日本における品質保証機能を牽引していただきます。担当領域および専門分野において、現行規制（GQP省令）に加え、PDxにおけるGDP/GMP QA規制への準拠を確実に推進し、事業および組織の持続的な成長を支えていただくポジションです。


Develop 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.

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Job Description

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 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 where required
• Support continuous improvement activities regarding areas of responsibility
• Support local business growth in line with global quality practices and local commercial priorities
• Engaging 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 required
• Identify, assess and manage regulatory risk proactively and provide senior management with key data to help drive decisions
• Engaging site inspections, preparing audits 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
• Working with local CMOs and global manufacturing to maintain continuous product quality excellence
• Key quality support for regulatory product-specific inspections
• Correspondence 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 intermediate level of English.

- 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.

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