Commercial Quality & Compliance Manager
|職務内容||〇 This role is of Quality & Compliance Manager for Commercial Quality in Japan supporting the Japan Commercial Quality & Compliance Leader.
〇 Responsible for implementing the Quality and Regulatory Compliance requirements; driving compliance to Abbott Global Quality/Regulatory Framework, Divisional Policies/ Procedures etc.
〇 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.
〇 Support Local Quality leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.
〇 Interface with Tech Services and Legal Manufacturers on Quality Complaints for Abbott products, ensuring timely investigation, resolution, closure & customer follow-ups. Proactively reviewing product complaints and address the trends in a timely manner.
〇 Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.
〇 Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.
〇 Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies)
〇 Ensuring implementation of effective CAPA program across operational site.
〇 Driving Supplier Qualification Program (Identification, Evaluation through Audits, Monitoring, Maintenance & Re-Qualification).
〇 Review Changes, Deviations, Investigations, Market Complaints & CAPA.
〇 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.
〇 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.
〇 Continuously drive for compliance with Abbott quality standards and regulatory requirements.
〇 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.
〇 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.
〇 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.
〇 Responsible for supporting for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial Quality lead.
|応募資格||〇 Bachelor Degree in Pharmacy/Science/Engineering.
〇 Must have been employed in the Medical Device/Pharmaceutical /IVD industry for a minimum of 6 years.
〇 Minimum of 8 years’ experience in Quality Assurance and /or Compliance in a regulated industry.
〇 Ability to effectively communicate in Japanese and English.
〇 Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.
〇 Strong ability to negotiate with stakeholders.
〇 Able to manage multiple priorities.
〇 Superior attention to accuracy and details.
〇 Strong English verbal and written communication skills with the ability to convey appropriate information with clarity and effectiveness.
〇 Strong knowledge of relevant medical device industry regulations for quality systems and compliance.
〇 Experience in conducting and handling audits and inspections.