|部署・役職名||ARDx Commercial Quality ＆ Compliance Manager|
• This role is of Quality ＆ Compliance Manager for Commercial Quality in Japan supporting the Japan Commercial Quality ＆ Compliance Leader.
• Responsible for implementing the Quality and Regulatory Compliance requirements; driving compliance to our company Global Quality/Regulatory Framework, Divisional Policies/ Procedures etc.
• Support the maintenance of the QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.
• Support Local Quality leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
• Interface with Tech Services and Legal Manufacturers on Quality Complaints for our company products, ensuring timely investigation, resolution, closure ＆ customer follow－ups. Proactively reviewing product complaints and address the trends in a timely manner.
• Collaborate with other global entities in fulfilling Field Corrective actions （FCA） resulted from Regulatory Field Safety Notifications.
• Provide relevant quality support for post market surveillance （PMS） activities, ensure timely executions to minimize, any product supply interruption.
• Facilitating Audits （Corporate Quality Audits, Regulatory Audits, ISO－Notified Bodies）
• Ensuring implementation of effective CAPA program across operational site.
• Driving Supplier Qualification Program （Identification, Evaluation through Audits, Monitoring, Maintenance ＆ Re－Qualification）.
• Review Changes, Deviations, Investigations, Market Complaints ＆ CAPA.
• Responsible for the Quality Control program for imported products that are distributed in the market
o Collect information on product quality and when concerning information is obtained, provide timely written report to appropriate management so that necessary and appropriate measures be taken.
• Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.
• Continuously drive for compliance with our company quality standards and regulatory requirements.
• Responsible for management and satisfactory resolution of product issues in a timely manner. Coordinate cross－functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.
• Coordinate and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.
• Responsible for coordination and management of site Quality metric tracking, trending and reporting activities. Assure metrics appropriately characterize the key performance indicators of the quality system.
• Responsible for supporting for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial Quality lead.
【必須（MUST）】BASIC QUALIFICATIONS | EDUCATION:
• Bachelor Degree in Pharmacy/Science/Engineering.
• Must have been employed in the Medical Device/Pharmaceutical /IVD industry for a minimum of 6 years.
• Minimum of 8 years’ experience in Quality Assurance and /or Compliance in a regulated industry.
• Ability to effectively communicate in Japanese and English.
• Strong analytical, communication, decision－making and leadership skills for interaction with external and internal customers and partners.
• Strong ability to negotiate with stakeholders.
• Able to manage multiple priorities.
• Superior attention to accuracy and details.
• Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
• Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
• Experience in conducting and handling audits and inspections.