QA Leader & Hinseki, PDx Japan

Benefits

Additional Information

Job Description Summary 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. 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 business level of English (both written and oral) - Strong managerial, people