Manager, Quality Assurance

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

職務概要 Role Overview

Roles and Responsibility as a Hinseki, Quality manager required under pharma MAH

• Using specialized knowledge of GQP and QMS regulations, assist the department and divisional head, having overall responsibility of Product Quality tasks including quality agreements with domestic and overseas manufacturers, etc., and perform appropriate GMP management work.
• As a GQP Officer on behalf of GQP system operation and maintenance management and quality assurance manager duties (shipping management, factory audit, change management, abnormal deviation processing, complaint processing, recall processing, self-inspection, education and training, quality standard documents) /Revision of arrangements/procedure manuals, etc.)
• Document management related to GQP ministerial ordinances and GDP guidelines (SOP creation and revision)
• Creating, revising or supervising the “Product Master Formula” which is a GQP document.
• Management of QMS-related records such as change/deviation management, education training, self-inspection, etc.
• Support for creating annual product reviews, management reviews, KPI report documents, etc.
• GMP manufacturing facility management for domestic and overseas manufacturers, etc. in cooperation with the CMO management department
• Execution or supervision of other work related to quality assurance.
• Participation in new product introduction/manufacturing site transfer projects (compliance with regulatory requirements, new drug or change application/approval acquisition support, quality assurance system construction)
• Support for departmental management regarding budget management and personnel management.
  
  

Roles and Responsibility as a Group Manager / Prof III-Quality-Quality

• Intake, Data, Review, Processing of quality information (complaints from medical institutions) domestically and overseas, arranging document exchange for record creation.
• Filing of related documents
• Preparation of translation draft of investigation report for domestic manufacturing facilities
• Coordination of sample activities in each country (activities related to obtaining actual products complained of)
• Creating responses to complaints and inputting them into the database
• Communication and cooperation with domestic and international stakeholders in other departments involved in complaint management, such as customers involved in complaints.
  
  

主な職務内容 Key Responsibilities

• Using specialized knowledge of GQP and QMS regulations, assist the department manager, and be responsible for establishing and maintaining an appropriate QMS management system by concluding and revising quality agreements with domestic and overseas manufacturers, etc.
• GQP Quality Assurance Manager On behalf of GQP system operation and maintenance management and quality assurance manager duties (shipping management, factory audit, change management, abnormal deviation processing, complaint processing, recall processing, self-inspection, education and training, quality standard documents) /Revision of arrangements/procedure manuals, etc.)
• Under QA and QMS responsibility, Creating, revising or supervising the “Product Master Formula” which is a GQP document,
• Management of QMS-related records such as change/deviation management, education training, self-inspection, etc.
• Support for creating annual product reviews, management reviews, KPI report documents, etc.
• QMS manufacturing facility management for domestic and overseas manufacturers, etc. in cooperation with the CMO management department
• Execution or supervision of other work related to quality assurance.
• Participation in new product introduction/manufacturing site transfer projects (compliance with regulatory requirements, new drug or change application/approval acquisition support, quality assurance system construction)
• Support for departmental management regarding budget management and talent management
  
  

求められる経験・スキル・知識 Qualifications / Education / Experiences

• Experiences:
• Strong QA and Production experience for 5 years+
• Ability/Skills:
• Longer than 3 year experience in Pharma GQP and GMP
• Knowledge of GQP/QMS ministerial ordinance and related laws with QMS/ISO13485 process.
• Ability to handle complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
• Flexible and adaptable with strong conflict management skills.
• Ability to work independently under pressure and prioritize multiple tasks
• Ability to lead and influence, and to support others within team
• Good organizational skills with people management
• Good written and verbal communication skills in Japanese and English
  

Competencies & Licenses (required Qualifications And Licenses)

• Pharmacist (Preferable)
• TOEIC 800 equivalent or higher
• Equivalent to MS Excel/Word Expert
  
  

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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