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パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。

Compliance Manager / コンプライアンスマネージャー (スポンサー監査対応)

求人ID 55976BR ロケーション 東京都, 東京都 仕事内容
治験の質を担保するために、規制当局(国内・海外含む)の査察や、スポンサー(依頼者)監査の対応・監査プロジェクトをマネジメントします。スポンサー監査時の窓口(メインホスト)として、requirementやスコープから、監査時のリスクを想定し、準備・計画から実施、評価までリードして頂きます。また、社内各部門から情報収集、リスクを共有しながら、臨床開発部/PV/DMなどの各部門を横断的に取りまとめ(コーディネート)、スポンサー監査プロジェクトをリードする業務です。

Job Purpose: Have a high level of knowledge and experience of appropriate GxP compliance and other applicable regulations and laws, Parexel procedures and appropriate Parexel processes to conduct audits and provide expert advice to internal and external clients. To effectively lead, matrix manages, develop, and implement assigned projects. To exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically.
Specialized Area:
The Compliance Manager will have a primary role in the management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area, as assigned by QA Senior Management. Alternatively, or in addition, the Compliance Manager can act as the QA Lead / QA Lead back-up for a Strategic Partnership or a client account for which QA representation is needed. Other duties may include the Auditor Coordinator role, as assigned.
Key Accountabilities:
• Work independently and as part of the QA team
• Act as expert GxP consultant in relevant area to groups within the Parexel organization and sponsors
• Train new and existing QA personnel
• Train and educate operational staff by the development and presentation of training courses
• In liaison with the QA management, promote compliance within the company and represent QA, as required
• Build, develop, and maintain good working relationships with internal and external customer
• groups
• For area of specialization, work with internal customers and develop and execute strategic audit
• Deputize for QA management within area of specialization
• Review the work of the matrix team to ensure consistency and quality within the group
• Act as a contact with members of Regulatory Authorities and / or sponsors; help lead in their
• audits / inspections in agreement with QA management
• Contribute to the information provided to QA management to summarize quality issues arising
• from audits and other related activities, as requested
• Plan and conduct complex audits / mock office inspections in agreement with QA management
• Ability to review and, if necessary, identify improvements that enhance the quality and clarity of
• audit reports
• Assist QA management in the development and implementation of strategic procedures and
• working practices to ensure continuous quality improvement
• Maintain relevant knowledge of both local and international auditing and appropriate GxP
• requirements and developments as they impact Parexel international SOPs and compliance
• with GxP, and communicate these to the QA team and QA management, as applicable
• Be familiar with GxP required computer system validation requirements
• Maintain and / or develop records / documents for assigned areas
• May serve as a member of industry association boards, task forces, and committees and / or as
• chairperson or officer of one or more professional associations. Contributes expertise to
• professional societies, academic, or other similar groups influential in his / her area of expertise
• Develop and maintain network contacts with other quality assurance professionals
• Travel on assignment
• Other duties as assigned

Additional Key Accountabilities and Skills Specific to Sponsor Audits and Regulatory Inspections:
• Host/support Parexel Sponsor Audits and Inspections as needed
• Evaluate Sponsor Audit and Regulatory Inspection processes for quality improvements
• Provide training for Sponsor audit and Regulatory Inspection activities


Qualifications

PMDA等、規制当局の査察対応の経験
スポンサー監査、ベンダー監査、治験実施医療機関監査対応等監査の実務経験必須
ビジネスレベル英語力

Knowledge and Experience:
•Extensive Sponsor Audit and inspectionexperiencein Quality Assurance, including applicable GxP auditing

Education:
• Educated to degree level (technology, biological science, pharmacy or other health related
discipline preferred) or equivalent qualification or clinical research experience
• Master’s degree in a science, technology or industry related discipline, preferred


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