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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Senior Auditor Quality Assurance

Job ID 63292BR USA - Any Region - Home Based
Home Based Role, Any Region US

The Sr 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 Sr 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


  • Ability to develop relationships with a culturally diverse group of key stakeholders within Parexel and the client’s business
  • Excellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessions
  • Excellent analytical skills
  • Ability to manage multiple and varied tasks, and prioritize workload
  • Experience with Microsoft based applications, and ability to learn internal computer systems
  • - Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork
  • Accurate and detail oriented
  • Excellent organizational skills
  • Motivated to work and perform consistently in a fast-paced environment
Minimum 5 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
  • Knowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferred
  • Ability to execute strategy and plans
  • High degree of flexibility and ability to adjust to changing priorities and unforeseen events

  • Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.).

EEO Disclaimer

Parexel 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.

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