General Electric Quality Assurance Leader - PDx Japan in Minato, Japan
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 in-depth knowledge of best practices and how own area integrates with others; has working knowledge of 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.
Roles and Responsibilities
GEHC ONLY Creates a Quality culture by driving compliance activities around a Life Sciences product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.
Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.
Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment.
Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.
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 office
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
Engaging assessment regulatory impact on product and manufacturing processes.
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
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 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
For roles outside of the USA- This role requires significant experience in the Quality & Life Sciences Quality. Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).
For roles in USA - Master'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 field
7 years experiences in medical device, pharmaceutical industry or other regulated industry
At 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 applications
Proficient with eQMS and eDMS systems
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 basic level of English (both written and oral)
Strong managerial, people guidance, project management and time-management skills
Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management skills.
Experience being in Sokatsu and Hinseki roles
Working experience in MNC pharmaceutical/medical device/healthcare product organizations
Experiences with CA/PA systems (GE electronic QA system)
Experiences applying regulations (GMP, Good Distribution Practices)
QC testing experience for sterile products
Technical transfer experience for QC test or manufacturing process for sterile products
Note: To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.
Relocation Assistance Provided: No