Quality Assurance Supervisor/Specialist- Japan

Job description

3133258
City

Shinjuku-ku
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

Japan
Postal Code

169-0073
Role Summary/Purpose

QA Supervisor/Specialist is one of the essential roles required by Japanese Pharmaceutical and Medical Device Act to establish a pharmaceutical organization and market pharmaceutical products.QA Supervisor/Specialist is responsible for leading GEHC – LS distribution/commercial site(s) to ensure compliance with current regulations and industry practices with regards to the area of responsibility and specialization e.g.
Essential Responsibilities

•Leading the development and maintenance of Quality System metrics
•Establish QA process and manage quality complaints from customers
•Leading the preparation and execution of Quality Management Reviews at the site
•Leading quality evaluation of warehouse operations, manufacturing sites, and external laboratories
•Provide support to routine activities, projects, development and training relevant to area of
Expertise
•Lead site selection process of local site(s) and external laboratory site(s)
•Support continuous improvement activities regarding areas of responsibility
•Assess regulatory impact on product and manufacturing processes. This may include acting as
quality expert and approval/authorization of regulatory specifications and submissions for one or
more sites
•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
•Translate new industry trends and requirements into business policies and practices
•Identify, assess and manage regulatory risk proactively and provide senior management with key
data to help drive decisions
•Maintain quality procedures up to date and reflective of regulatory requirements
•Conduct Quality System audits of area and suppliers, warehouses, 3PLs, prepare and execute
Quality Management System (QMS) reviews, as applicable
•Responsible for hosting site inspections, preparing audits observations response as necessary
•Own compliance assessment and remediation plans while influencing execution, communications
and training for Quality matters
•Responsible for coordinating and performing training relative to the warehouse and other
responsible area, QMS principles and on the global QMS procedures as required.
•Secure that a QMS system is operational and support implementation of QMS at any new or
existing Pharma operation relative to local and/or regional operations
Qualifications/Requirements

1. B.S. Degree in business or technical field
2. QA supervisor (Hin-seki in Japanese) experience preferred
3. 5 years experience in medical device, pharmaceutical industry or other regulated industry
4. 3 years experience with CA/PA systems, including complaint handling
5. 3 years experience applying regulations (GMP, Good Distribution practices)
6. Proficient with MS Office word processing, spreadsheet, presentation, and database applications
7. Ability to identify root cause of problem and creatively problem solve to gain resolution
8. Ability to work independently in fast-paced environment with little supervision.
9. Ability to adapt to constant change and influence positive change effectively
10. Team-oriented and responsive to customer needs
11. Quality-focused, attentive to detail and results-oriented
12. Ability to communicate effectively in Japanese and English (both written and oral)
13. Ability to form, lead, and manage cross-functional and cross regional teams
Desired Characteristics

1. Familiar with Continuous Improvement methodologies, including Six Sigma
2. Excellent project management skills
About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.