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Job Details

Sr. QA Auditor (Senior GCP Auditor)

Company: Chiltern
Location: Home or Office based in the U.S.
Reference: 6520
Closing Date: 22 Mar 18
Type: Full Time
Salary (£): On Application
Benefits: Excellent and competitive benefits

Job Summary:

The Senior QA Auditor is responsible for Quality Assurance aspects of clinical trials, ensuring trials conform to ICH-GCP, other applicable regulations and the relevant Standard Operating Procedures (SOPs). The QA Auditor is independent of the Clinical Research Team.


Job Background


In this role, the main overall responsibilities of the position are the following:

  • Plan, prepare and conduct trial specific, quality system, and vendor qualification audits and report findings to the auditees.
  • Create QA SOPs required for the proper functioning of the clinical trial process.
  • Act as Quality Project Lead (QPL) on assigned studies, ensuring quality related oversight of projects and to act as a QA point of contact for study team members.
  • Audit the quality of the clinical trial against the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local requirements; prepare audit reports within a timely manner; identify any failure to meet the standards and address the issue immediately with the Project Manager; and if required, with Chiltern Senior Management.
  • Hosts client audits and supports regulatory inspections activities (as applicable).
  • Provide regular feedback to the QA Audit Management team about the quality standards practiced in the company and give recommendations for their improvement.
  • Conduct project specific, internal system audits and vendor audits to assess the quality standards and provide recommendations; prepare audit reports within a timely manner.
  • Provide GCP consultancy and advice in response to questions raised by individuals from the organization.
  • Ensure that systems and processes agreed and implemented by management will ensure that Clinical Trials have been performed, and data is generated, in compliance with ICH-GCP and other applicable regulations.
  • Be aware of updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance.

Desired Skills and Experience

  • University Degree in a biomedical or related life science, or nursing preferred
  • Minimum 5+ years of experience, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Must have experience preforming clinical site audits (GCP)


depends upon experience

Position Type

Full Time


Email Michelle Gerardi -
+1 774 272 5506

Apply for this job: Sr. QA Auditor (Senior GCP Auditor)

Contact Information:

Address:  Illinois, USA
1425 Tri-State Parkway, Suite 110 Gurnee, USA
IL 60031
Website:  Visit Our Web Site

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