GE HealthCare QA Leader & Hinseki PDx 

Japan, Tokyo 

438170758

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.

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.

- 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 ERP/WMS systems such as SAP

- 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.

- Quality-focused, attentive to detail and results-oriented

- 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

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.