Job Description

【職務概要】

弊社が治験依頼者として実施するすべての臨床試験において、患者の安全性、高品質なデータ、及び企業の要求事項や規制の遵守が重要です。Country Clinical Quality Manager（CCQM）の役割は、これらの目標を達成する上で大きな影響を持っています。

Reginal Director（RCQM）の指導の下、CCQMは日本におけるすべてのCQM活動を監督します。

この役割には、ローカルとグローバルのプロセスや手順を適切に実施する能力、プロセス改善の機会を特定する能力、そして継続的改善活動のイニシアチブをサポートする能力が求められます。さらに、CCQMは監査、GCP適合性調査、Quality Control及びローカルのトレーニング活動もサポートします。

【期待される役割】

Quality Specialistとして国内外の関連する規制に精通し、開発関連部門と連携し、PMDA適合性調査の対応や、Audit findingに対するCAPA対応、プロセス管理など、臨床試験のQuality全般のマネジメントに関わる業務を担当いただきます。

海外の同僚と議論できる英語力、プレゼンテーションスキル、様々な部署との調整など円滑なコミュニケーションスキル、ロジカルシンキングや問題解決力、そして新しいことを学ぶ意欲を持っていることなどが、必要な資質です。

【業務内容】

適合性調査のマネジメント及び監査のCAPAマネジメントQuality Control活動、プロセスマネジメント及び改善活動を含むClinical Quality ManagementIssue managementトレーニングの調整と提供Local Supplier Qualificationローカル試験のリスク評価及び臨床試験実施のサポート（日常のQualityに関するコンサルテーション

【必要とされる経験、スキル】

経験：

Auditor、Inspection manager又はQuality manager等として、GCP適合性調査のマネジメント、監査のCAPAマネジメント、プロセス管理といったQualityの活動経験が、3年以上ある臨床試験、GCP及び適応される規制の深い知識と理解を有しているトレーニングの調整と実施の経験があるクロスファンクショナルチームをリードした実績がある

スキル：

言語；日本語（ネイティブ）及び英語（ビジネスレベル）グローバル環境における優れた口頭及び書面でのコミュニケーション能力とリーダーシップスキルプレゼンテーションスキルロジカルシンキング、問題解決力及びRoot Cause Analysisの知識

※Quality Managerとありますが、Manager職ではなくSenior Staffでの採用となります。

【Job Description】

It is critical that, for all company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The Country  Clinical Quality Manager (CCQM) position has a significant impact in achieving those objectives.

Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in Japan.

The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, GCP inspections as well as Quality Control and local training activities.

【Expectation】

This role needs deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research related regulations as quality specialist and collaborate with study teams to manage PMDA inspections, CAPA responses to audit findings, process management and other tasks related to the overall quality management of clinical studies.

Required qualifications include English skills to discuss with overseas colleagues, presentation skills, smooth communication skills such as coordinating with various departments, logical thinking and problem-solving skills, and a desire to learn new things.

【Job】

Inspection management and Audit CAPA managementClinical Quality Management including Quality Control Activities, Process Management & Improvement.Issue managementCoordinating and delivering training sessionsLocal Supplier QualificationSupport for risk assessment of Local studies and execution supports (daily consultation related to quality)

【Qualification, Experience and Skills】

Experience;

A minimum of 3 years of relevant experience in Quality activities such as GCP Inspection management, audit CAPA management, process management as Auditor, Inspection Manager, Quality manager etc.Deep knowledge and understanding of Clinical Trial processes, GCP and applicable clinical research related regulations.Experience in coordinating and delivering training sessions.Demonstrated experience in leading cross-functional teams.

Skills;

Language: Japanese (native) and English (business level)Superior oral and written communication and leadership skills in a global environment.Presentation skillLogical thinking, problem-solving skills, and knowledges of Root cause analysis

※This position is not a Manager position but Senior staff position.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

06/30/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R328119