GCP Compliance Manager

1週間前

Tokyo Parexel Full time

When our values align, there's no limit to what we can achieve.

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、クライアント(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。クライアント監査時の窓口(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、また、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、クライアント監査プロジェクトをリードする業務です。

【職務内容】

  • 監査や査察の準備・計画・遂行
  • プロジェクトや監査状況の把握
  • クライアントや社内部署との良好な関係構築
  • マネジメントへの監査計画や戦略の提供
  • プロセスやその改善の認識、マネジメントへのインプット
  • QAメンバーへの指導、トレーニング

    • 【応募対象者】

  • PMDA等規制当局の査察対応の経験、スポンサー(依頼者)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
  • 医薬品メーカー、CRO QA経験シニアレベル 約5年以上
  • 監査・査察対応・監査プロジェクトマネジメント経験
  • ビジネスレベルの英語力(直属上司グローバル:在シンガポール)

    • The Quality Assurance (QA) Compliance Manager has an in-depth 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.

    The Compliance Manager will have a relevant 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.

    Management/coordination/oversight of QA compliance GxP activities in a specific geographical and/or functional/specialist area, as assigned by QA Sen Management

  • Work independently and as part of the QA team
  • Act as expert GxP consultant in relevant area to groups within the Parexel organization and Parexel clients.
  • In liaison with the QA management, promote compliance within the company and represent QA, as required.
  • For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.
  • Act as assigned as QA Lead for a Strategic Partnership or a client account for which QA representation is required.
  • Contribute to the information provided to QA management to summarize quality issues arising from audits and other related activities, as requested.
  • In liaison with the QA management matrix, manage projects, including teams of multifunctional personnel, as needed.
  • Review the work of the matrix team to ensure consistency and quality within the group.
  • Deputize for Sen Compliance Manager and QA management within area of specialization.

    • Work closely with Regulatory Authorities and Clients. Support regulatory inspections & client audits as needed.

  • Act as a contact with members of Regulatory Authorities and / or clients; help lead their audits / inspections in agreement with QA management.
  • Act as key contributor for review of client audit/regulatory inspection findings.
  • Provide strategic feedback and trending for Regulatory Inspectorates and client audits.
  • Review and contribute to Requests for Information (RFI) as assigned.
  • Conduct mock office inspections in agreement with QA management.
  • 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 QA professionals.

    • Act as QA Lead for billable audit programs or a client account for which QA representation is needed (as applicable)

  • Oversee billable audit programs.
  • Create and maintain the Audit Process Plan (APP) for the program.
  • Coordinate billable audits across all regions.
  • Act as main client contact and the Parexel project team
  • Request assignment of auditors by Parexel QA management.
  • Provide auditors with the information required to schedule their assigned audits.
  • Review audit reports and responses to ensure consistency in audit conduct, report writing and follow-up for the program.
  • Raise a Change in Scope (CIS) if QA services outside of the APP are requested by the client.

    • Maintain knowledge of project /audit status in assigned areas

  • Plan and conduct complex audits as assigned across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, safety/pharmacovigilance (PV) audits.
  • Manage projects as assigned, including teams of multifunctional personnel, as needed.
  • For area of specialization, work with internal customers and develop and execute strategic audit plans for the area.
  • Review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.
  • Maintain and / or develop records / documents for assigned areas.

    • Process Improvements

  • Assist QA management in the development and implementation of strategic procedures and working practices to ensure continuous quality improvement.
  • Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports.
  • Analyze audit activities and provide metrics to relevant parties (QA, Operations, Procurement).

    • Provide Trainings

  • Develop and present training courses as needed.
  • Train new and existing less experienced QA personnel.
  • Train and educate operational staff by the development and presentation of training courses.
  • Mentor new QA staff as assigned.

    • Build and maintain relationships

  • Build, develop, and maintain good working relationships with internal and external customer groups.
  • Work well in team environment.

    • Perform other quality related task or projects as assigned

  • Perform other quality related tasks or duties as assigned.
  • Travel internationally on assignments as required. Travel time could be up to approx. 60%.

    • Qualification /Minimum Work Experience

    Extensive experience in quality assurance, regulatory affairs, auditing, or other relevant area including applicable GCP auditing

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