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Compliance Manager

Company: PAREXEL
Location: Norwell
Posted on: September 17, 2020

Job Description:

East Coast Home Based with travel to Newton, MA and Durham, NC

The Compliance Manager (Principal Auditor) will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, procedures and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. Auditors must be detail oriented, able to maintain a big picture / overview on the project / business, 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. In liaison with QA Management and staff, provide direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance.

Specialized Area:

The GCP Auditor should have a thorough understanding of Clinical Trials and Clinical Development, combined with an in-depth knowledge of ICH-GCP, other international GCP regulations / standards (e.g. as applicable: EU Clinical Trial Directive, US FDA Code of Federal Regulations) and, as required/ applicable, local relevant GCP guidance /regulations . The GCP auditor contributes to the execution of the GCP QA annual audit plan as assigned, may perform client contracted/billable audits, provides GCP consultancy to internal/external clients, where appropriate, and may contribute to the preparation/coordination/hosting/follow-up of client audits and/or regulatory inspections with a GCP focus, as assigned.


  • Conduct risk-based GCP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, pharmacovigilance (PV) audits
  • Local, regional or global consultancy with regard to the implementation of GCP and PV requirements, and implementation of regulatory requirements in these areas
  • Provide support and resources for regulatory inspections & sponsor audits
  • Liaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of GCP and PV requirements across the Parexel Corporation


    Key Accountabilities:


    • Facilitate sponsor audits / regulatory inspections, as assigned
    • Fosters a good working relationship with internal and external clients
    • Working knowledge and expertise of Parexel policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as needed
    • Promotion of compliance within the company
    • Plan and conduct audits, including global and complex assignments, delivering a written report
    • Proactively provide input to management on audit plans / strategy
    • Proactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriate
    • Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
    • Maintain QA oversight and deliver QA consultancy for assigned countries/departments
    • Maintain and / or develop records / documents related to assigned areas
    • Mentor and assist with training of less experienced auditors
    • Travel on assignment


      QualificationsSkills:


      • Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the clients business
      • Excellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessions
      • Ability to manage multiple and varied tasks, and prioritize workload
      • Experience with Microsoft based applications, and ability to learn internal computer systems


        Knowledge and Experience:


        • Substantial experience in quality assurance, regulatory affairs, auditing, clinical research, monitoring, data management, pharmacy, laboratory, or other relevant area, including sound experience of applicable GxP audits
        • Minimum 7 years of GCP auditing experience of Early Phase and Late Phase clinical trials in the CRO and/or Pharma industries required


          Experience hosting sponsor audits & regulatory inspections highly preferred


          • Direct CRO or Pharma experience preferred in GCP auditing
          • Experience at conducting:


            • GCP Late Phase Investigator Site Audits
            • Trial Master File
            • Third Party Suppliers
            • System/ Process Audits
            • Pharmacovigilance Audits
            • Good knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) required


              Education:


              • BS/ BA degree or equivalent experience



                EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Keywords: PAREXEL, Boston , Compliance Manager, Executive , Norwell, Massachusetts

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