・Identify and lead the implementation of continuous improvement (process and quality) focus on exceeding customer needs
・Lead the establishment of GVP procedures and formats in the Japan commercial office
Ensure GVP activities are implemented and maintained to MHLW GVP Ordinance and Corporate procedures
・Prepare records regarding collection of safety information from various sources, e.g. medical personnel, society, paper, research, foreign/domestic health authorities, competitors and SNS
・Preserve all safety records properly
・Evaluate safety information, record the assessment and plan safety measures if required
・Lead the implementation of safety measures, e.g. recall, stop shipment, report to health authorities, IFU update, preparation and distribution of safety information to medical personnel and distributors
・Identify and manage projects to improve the effectiveness of the GVP
・Participate, as required, in the internal corporate audit and external audit program
・Coordinate all the preparation and hosting activities in internal corporate or external audits relating to GVP and act as a Safety Manager for the Japan commercial office
・Escalate nonconformities in the Japan office to Marketing Supervisor General, where appropriate
・Responsible for identifying issues that need CAPA
・Oversee the CAPA and Internal audits processes related to GVP to ensure they are working effectively
・Work with Corporate complaint handling team, Japan Clinical, Customer Support team and other functions on compliance and GVP improvement activities
・Facilitate key quality metrics and develop collection, analysis, and reporting systems, which promote timely communication and corrective action
・Conduct periodic self-assessment in the Japan office and provide GVP related training for the organization
・Responsible for the effective fulfillment of objectives and deadlines assigned
・Participate in team efforts to achieve departmental and organization goals
・In depth knowledge of Quality System regulations – ISO 13485, MHLW QMS/GVP Ordinances and PMD Act.
・Must interact well with all levels of management, co-workers, and regulators. Incumbent must possess strong written, verbal and interpersonal communication skills and work independently as well as in close collaboration with others.
・Ability to do research and come up with creative, compliant solutions for quality challenges.
・Demonstrated leadership; proven track of managing projects/people deploying planning, executing/validating and implementing phases.
・Attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects.
・Computer skills including Word and Excel.
＜EDUCATION and/or EXPERIENCE＞
・Bachelor degree is required; Engineering or Science preferred
・Minimum 8 years working experience in RA and/or QA Organization is required; preferably in medical device industry
・2 years minimum experience leading teams of professionals in achieving company goals/projects
・Work experience in an American and/or European company is desired
＜SKILLS REQUIRED: LANGUAGE SKILLS＞
・Fluent English required (reading, writing, and conversation)
・Excellent written and oral communications and ability to synthesize information to present internally as well as to regulatory agencies