Senior GCP Auditor

Job Description:

The Senior GCP (Good Clinical Practices) Auditor is responsible for conducting assigned audits per the published audit schedules. The Senior GCP Auditor will plan, conduct, report and follow up on all types of GCP audits, including internal audits, contracted audits and vendor audits. The Senior GCP Auditor will also provide support during client audits and regulatory inspections and will support all relevant activities associated with the Quality Management System.

Qualifications:

• Bachelor’s degree in Life Sciences or related field required.
• RQAP GCP or similar certification strongly preferred.
• 5 years of relevant GCP auditing experience in a regulated environment such as pharmaceutical, biotech or CRO or similar environment required.
• Knowledgeable in relevant regulations and guidelines including 21CFR-Part11 and ICH GCP.
• Fluent in Microsoft SharePoint, Outlook, Word, Excel, and PowerPoint.
• Prior experience with electronic Quality Management Systems preferred.
• Driving/Travel requirements - Travel up to 10% (US, Canada, or International).
• Ability to travel as needed to conduct investigator site audits or vendor audits, to support client audits, etc