9件の東京都でのhead of qaのおすすめの求人

Head of Quality Assurance
Clinigen —中央区日本橋室町
- 一部在宅
- Microsoft Office
- データベース経験
- 大卒
クイック応募
QA Manager
Vantive —江東区新砂
Media & Data Marketing Manager
Visa Worldwide (Japan) Co., Ltd. —千代田区
- 営業経験
R&D Clinical Quality Assurance Associate Director
MSD —千代田区
- 管理職・マネジメント経験
- 英語
- プレゼンテーションスキル
Supervisor Customer Service
Ria Money Transfer (Dandelion) —千代田区
- Microsoft Office
クイック応募
14日前
Dev012_ML Lead Engineer / 業務委託
株式会社カウシェ —渋谷区神南
- 機械学習
- Python
【Chief Transformation Office】Project Manager/Business Analyst - Risk Change
野村證券株式会社 —東京都 23区
- PMP
- SQL
- コミュニケーションスキル
管理職採用/PdM/PjM/AI英語学習サービス/abceed/プロダクト開発をリード/プロジェクトマネージャー(Web・オープン系)/東京都/正社員
株式会社Globee —港区麻布十番駅
- 年収 700万円 ~ 1,199万円
- 管理職・マネジメント経験
- 英語
- ソフトウェア開発
- 有給休暇あり
- 在宅OK
9日前
【Chief Transformation Office】Project Manager − Risk
野村證券株式会社 —千代田区大手町
- 二か国語
- PMP
- Microsoft Office

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Head of Quality Assurance

Clinigen -
中央区日本橋室町

クイック応募

求人の詳細

資格とスキル

日本語
Microsoft Office
データベース経験
大卒

仕事内容の詳細

Position summary

Provide leadership and oversight as the Quality Assurance Responsible Person mandated by the Pharmaceuticals and Medical Devices Act, ensuring continued compliance with regulatory requirements and the maintenance of the company's pharmaceutical business license.

Key accountabilities

Implement and ensure compliance to the QA processes for medical product in Japan, in compliance with the local regulations/ standards; Global QA registration/ standards; and policies/ procedure at a local, regional and global level
Developing, promoting and auditing quality assurance processes and practices, ensuring the Group’s internal standards are met and the highest possible external inspection ratings are achieved.
Developing continuous quality improvement methodologies and innovative quality assurance offerings that will add value in revenue growth and that will deliver excellence to clients, exceeding commercial and compliance requirements.
Meeting all requirements and carrying out all duties expected of the statutory titles held. Ensure appropriate liaison with Medical Affairs, Regulatory, Supply Chain, Quality, Commercial, Legal, etc., to ensure Quality Assurance input into the company's strategic planning for products through their lifecycle.
Communicate Quality Assurance concerns with or provide feedback regarding QA activities in Japan to the General marketing compliance officer and Global QA management.

Major Tasks & Activities:

Essential Duties and Responsibilities.

Legally stipulated Quality Assurance Manager
In the capacity of Quality Assurance Manager have an oversight of all QA activities as per applicable local legislation.
Ensure adequate understanding of audit and inspection preparation and readiness. Give necessary instructions to each department of the company.
Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities as per identified roles.
Ensure compliance with document management procedures for retention and archiving.

Understand and implement the document change management process and act as SME (Subject Matter Expert) for procedures.
Ensure all training requirements for the role are met.
Identify appropriate stakeholders and ensure they are trained on QA requirements/ procedures.
Build alignment and collaboration with Regulatory Affairs, Medical Affairs, Supply Chain, PV, and Commercial.
Communicate effectively all relevant QA related compliance concerns with the Global QA management.
Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan) With regards to third party agreements
Ensure the appropriate QA language is incorporated into 3rd party agreements. Perform regular review of the agreements to ensure QA requirements are aligned to the current regulation requirements and perform reconciliation of data between third parties and the company
Respond to submission related queries from the regulatory authorities and archive all regulatory related correspondence.
Oversee and monitor the transfer of product licenses to and from the company to assure data integrity and continued compliance with regulatory requirements.

Team management

Establish and monitor budgets and forecasts.
Manage and support of QA personnel.
People hiring, coaching and development of new QA personnel.
Provide feedback and regular reporting QA activities to the General marketing compliance officer and Global QA management.
As required, participate in JAPAC meeting or other meeting as the Japan function head and collaborate with applicable departments.

Vendor/Third party Management

To verify that the service provider is qualified to perform the outsourced QA activities prior the service starts.
To write the Service Agreement (SA) and or QA Agreement as per JAPAC and Japan requirements.
Maintain close contact with the Person Responsible for Implementation of QA at the contractor company for keeping outsourced work properly and smoothly.
To monitor whether outsourced QA activities are performed in compliance with the contract requirements and KPIs by quarterly meetings.
If the implementation of QA activities outsourced needs to be improved, instruct the contractor to take necessary actions.
Understanding of QA vendor service standards and requirements – ability to develop and monitor key performance indicators

Requirements

At least 10 years of QA work experience in the pharmaceutical industry. (Mandatory)
Extensive knowledge of QA including international aspects.
Bachelor's degree in biology or chemistry or other life sciences
Confidence in dealing with senior management and employees at all levels, especially with the ability to work and make decisions autonomously.
Experience working with QA databases and Microsoft Office software
Native-level Japanese and full professional proficiency in English

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東京都の求人 head of qa 件

Head of Quality Assurance

QA Manager

Media & Data Marketing Manager

R&D Clinical Quality Assurance Associate Director

Supervisor Customer Service

Dev012_ML Lead Engineer / 業務委託

【Chief Transformation Office】Project Manager/Business Analyst - Risk Change

管理職採用/PdM/PjM/AI英語学習サービス/abceed/プロダクト開発をリード/プロジェクトマネージャー(Web・オープン系)/東京都/正社員

【Chief Transformation Office】Project Manager − Risk

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