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Job Function:
QualityJob Sub Function:
Customer/Commercial QualityJob Category:
ProfessionalAll Job Posting Locations:
Chiyoda, Tokyo, JapanJob Description:
SCOPE OF THE ROLE AND BASIC PURPOSE
Key Responsibilities
In the EP/NV Quality assurance, Quality& Regulatory Compliance, based on compliance with laws and regulations and internal regulations (J & J Standard, etc.) and the quality management system, establish the system and manage and supervise the overall QMS system, including the management of NC/CAPA, Internal Audit management, Quality system management review, Record management and audit response. In addition, he/she shall accurately grasp the needs of customers and businesses, build a good, trusted relationship with each FC, 3 rd party, and stakeholders (including overseas), and establish more efficient QMS business processes.
Experience and Skills:
Required:
Knowledge and practical experience of laws and QMS ministerial requirements
Proactive approach/ Able to appropriately demonstrate unique initiatives
Logical Thinking, Decision Making, and Problem-Solving Skills
Has a strong commitment to achieving goals and a flexible ability to execute.
Excellent written and oral communication skills among government, 3 rd parties, organizations, and individuals.
Business level English proficiency (Conversation, reading and writing)
Project and Team Leadership
Ability to multitask.
Preferred:
At least 3 years of experience in quality system/quality assurance/quality control and safety management. (This is acceptable if you are in the pharmaceutical or medical device industry)
Internal/External Audit Implementation and Response Experience (QMS Auditor License Holder)
Experience in the cross-culture/global environment
IT/Digital literacy
Education:
Bachelor's degree or educational equivalent (Health science or other directly related field or equivalent combination of education is preferred).
主要な責務
EP/NV Quality assurance Quality& Regulatory Compliance において、法規制や社内規定(J&J Standard等)の遵守及び品質マネジメントシステム（QMS）に基づき、日本の市場における製品及びサービスに関するNonconformance/CAPA管理、内部監査の管理、マネジメントレビュー、品質記録管理、監査対応などQMS全般の体制構築及び管理監督を行う。 また、顧客・ビジネスのニーズを的確に把握し、各事業部、3rd party、ステークホルダー（海外含む）との良好な信頼関係を築き、より効率的なQMSの業務プロセスを確立する。
経験とスキル：
必須：
法令及びQMS省令の要求事項の知識と実践経験
プロアクティブなアプローチ/独自のイニシアチブを適切に発揮できる
論理的思考、意思決定、問題解決スキル
目標達成に対する強いコミットメント及び柔軟性のある実行力を有する。
行政、3rd party、組織及び個人間における文書及び口頭による優れたコミュニケーション能力。
ビジネスレベルの英語力（会話、読み書き）
プロジェクトおよびチームリーダーシップ
マルチタスク遂行能力
Preferable：
品質システム・品質保証・品質管理または安全管理における3年以上の経験。（医薬品または医療機器業界であれば尚可）
Internal/External監査実施及び対応経験(QMS Auditor License Holder)
クロスカルチャー/グローバル環境での経験
IT/デジタルリテラシー
Education:
大学卒業 (大学卒業以上またはそれと同等の資格を有する者）
Required Skills:
Preferred Skills:
Business Behavior, Compliance Management, Continuous Improvement, Data Analysis, Data Compilation, Detail-Oriented, Execution Focus, Goal Attainment, Internal Controls, Issue Escalation, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report WritingSkills Required
- Excellent Communication skill in Japanese
- Good English Communication
- Logical Thinking/Decision Making
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
