Japan Head of Commercial Qualityï½ä¸çã®ãããã¯ã©ã¹ã»ãã«ã¹ã±ã¢ä¼æ¥
Japan Head of Commercial Qualityï½ä¸çã®ãããã¯ã©ã¹ã»ãã«ã¹ã±ã¢ä¼æ¥
Posted on :
23-08-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Description
Head of Commercial Quality Japan
1.
2.
3.
Rapid Diagnostics (RDx)is part of our Diagnostics family of businesses bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing. This testing provides crucial information for the treatment and management of diseases and other conditions.
The position of Head of Commercial Quality is within our Rapid Diagnostics (RDx) business responsible for the quality management of our Rapid Diagnostics Medical Company Ltd. This role will be directly responsible for implementing and maintaining RDx Japans Quality Control program for imported products ensuring proper handling of customer complaint resolution and managing the local Quality Management System in compliance with our ISO requirements and country-specific regulations.
Additionally this role oversees the RDx Commercial Quality employees within Japan.
This job description will be reviewed periodically and is subject to change by management.
RESPONSIBILITIES:
- Holds theposition of General Marketing Supervisor(Sokatsu)for RDx Japan managing all the Business Units under RDx.
- Performs the duties of General Marketing Supervisor(Sokatsu)of Medical Devices for quality control activities according to PMD Act ArticleParagraph 2.
- Accountable for being Management representative with Responsibility & Authority for the Quality and Regulatory requirements; ensuring compliance to our Global Quality/Regulatory Framework Divisional Policies/ Procedures.
- Responsible for proactively creating Quality Culture w.r.t People Process Products & Services to meet customer needs.
- Maintain QMS in Japan market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.
- Must interface and represent commercial president in areas of quality decisions such as escalations field actions and/or other significant quality issues.
- Oversee Quality Complaints for our 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/Approve Changes Deviations Investigations Market Complaints & CAPA.
- Responsible for Budgetary Planning for Quality Operations.
- Evaluate the existing Quality Management System implemented in the country with the our QMS and Business Unit Quality Standards and Procedures and conduct gap analysis develop a remediation plan and drive it to achieve highest level of compliance.
- Responsible for the Quality Control program for imported products that are distributedin Japan according to Ministerial Ordinances169.
- To supervise the duties of the manufacturing control and quality control such as decision of release of the products and to bear a responsibility for the duties.
- When it is deemed necessary to fairly and properly perform the duties to give a necessary opinion in writing to the marketing approval holder the top management and other persons responsible for the duties concerned and to retain its copy for 5 years.
- To supervise the domestic quality assurance manager.
- To respect the opinions of the management representative and the domestic quality assurance manager.
- To have the units related to the manufacturing control or quality control and the Safety Control closely collaborate with each other.
- 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 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 with entity management 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.
- This position will be the Commercial Quality representative for internal compliance and 3rd party audits / inspections. Coordinate and manage all commercial audits in conjunction with the Commercial office lead.
- Implement new or modify existing processes to maintain compliance with local entity business unit division corporate voluntary standards and regulatory requirements.
- Other duties as assigned.
We provide reasonable accommodation to qualified individuals with disabilities.
RapidDiagnosticsRDx
RDxISO
- QMS
- PMS
- CAPA
- CAPA
- QMSQMS
- QMS71
- CAPAQMS
- QMS
- QMSKPI
BASIC QUALIFICATIONS EDUCATION:
- Must be a licensed Pharmacist in Japan and have been employed in the MedicalDevice/IVD/Pharmaceuticalindustry for a minimum of 8 years.
- Minimum of 10 years experience in Quality Assurance and /or Compliance in a regulated industry.
- Minimum of 4 years supervisory / managerial experience
PREFERRED QUALIFICATIONS:
- Ability to effectively communicate in Japanese and English.
COMPETENCIES:
- 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 and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses.
- Superior attention to accuracy and details.
- Strong leadership skills including the ability to set goals and provide constructive feedback respectfully in order to build positive relationships and improve business results.
- Capable of understanding and overcoming different cultural and language barriers to provide solutions that satisfy corporate regional and local objectives.
- 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.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work effectively within a team in a fast-paced changing environment. Multi-tasks prioritizes and meets deadlines in timely manner.
- Experience in conducting and handling audits and inspections.
- /IVD/8
- 10
- 4
23
Required Experience:
Director
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
