Assoc Mgr, Quality Control

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＞

東京工場のQCグループのマネジャーとして、シニアグループマネジャーをサポートし、グループ業務の運営を担う。

• 所属するグループの業務に関する戦略及び計画の立案、遂行、達成に貢献する。

• 製品の品質改善及び法令順守の維持を実現するための方策を考え、実行する。

• 専門的な知見をもって業務効率を高めるための方策を考え、実行する。

Support the senior group manager and is responsible for running the group's operations as the manager of the QC group at the Tokyo plant.

• Contributes to the planning, execution and achievement of strategies and plans related to the group's operations.

• Consider and implement measures to achieve product quality improvement and maintain the compliance with regulations.

• Consider and implement measures of work efficiency improvement with professional knowledge.

＜職務内容＞

• グループの目標達成のために、提案を行い、実践躬行する

• 品質管理業務の効率的な遂行

• GMP/QMS省令に基づく責任者の役割を担い、その業務を遂行する

• 品質システムを構築し、そのメトリクス指標を改善する

• 製品の品質水準及び法令順守の向上のための改善計画を立案し、実行を主導する

• 規制当局及び社内による監査（GMP、QMS）対応

• 社内関連部門及び関連行政との良好な関係を維持・構築する

• 海外関連製造所と良好な関係を維持・強化し、継続的な品質改善に貢献する

• 組織における社員（契約、派遣社員含む）のOJT及び指導を行う

• GMP/QMS教育の計画を立案し実行する

• 医薬品製造管理者（副）の責務を担う

• 医療機器責任技術者（副）の責務を担う

• Make a proposal to achieve the group's goals, and lead the implementation

• Execute quality control operation efficiently

• Carry out the role of the person responsible under the GMP/QMS ministerial ordinance

• Establish Quality Management System and improve the KPIs

• Develop improvement plan of product quality and compliance, and lead the implementation

• Comply with GMP/QMS inspection by Global cooperation and regulatory authorities

• Maintain and build good relationships with internal departments and related regulatory authorities

• Maintain and strengthen good relationships with overseas affiliated manufacturing plants, and contribute to continuous quality improvement

• Conduct the coaching and OJT of employees (including contractor, temporary staff) in the organization

• Develop and implement GMP/QMS training program

• Responsible for the role of deputy Product Security Pharmacist

• Responsible for the role of deputy Responsible Technical Manager

＜求められる経験・スキル・知識＞

• 薬剤師の資格必要

• 医療機器又は医薬品の品質管理又は品質保証に関する実務経験及び知識

• 医薬品医療機器等法、QMS/GMP省令等、関連する法規制

• 英語での交渉能力（TOEIC 700以上あれば尚可）

• 品質管理手法（サンプリングと抜き取り検査、管理図表、等）の知識があれば尚可

• 業務改善及び効率化に対する探究心及び実践力

• Project management skillの理解及び実践力

• 品質改善方法論（シックスシグマ、Process Excellence、Kaizen、等）の知識

• People management skill、３人以上のメンバーの管理経験

• PCスキル　Windows/Office（Word、Excel及びPowerPoint等）

• Pharmacist qualification is needed.

• Work experience and knowledge on Quality control or Quality assurance of Medical devices or Pharmaceuticals

• Pharmaceutical and Medical Device Act, GMP/QMS Ministerial Ordinance, Related Laws and Regulations

• English skill (TOEIC 700 or more is acceptable)

• Knowledge of quality control method (sampling and sampling inspection, control chart, etc.,)

• Curiosity and practical ability to improve business operations and streamline operations

• Understanding and practical ability to implement project management skills

• Knowledge of quality improvement methodology (Six Sigma, Process Excellence, Kaizen, etc.)

• People management skills, experience managing 3 or more members

• PC Skil: Windows / Office (Word, Excel, PowerPoint, etc.)

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.