West Chester, Pennsylvania
GCPA - GCP Auditor Job Opening in West Chester, Pennsylvania - Job Summary
This position is responsible for providing Global audit support and GCP oversight of Clinical Operations teams to the Head of QA-GCP. This job will include the execution and management of client's GCP audits and GCP guidance and advice across assigned departments within the Development Trials group.
Summary of the Essential Functions of the Job
Plan, schedule and conduct audits of Clinical Investigator Sites, CROs, and Clinical submission documents.
Assist in development and review of responses and corrective actions related to audit activities and reports.
Actively manage GCP advice and support to client's Development Operations and other relevant Clinical functions.
Stay abreast of clinical trial requirements, FDA, ICH GCP, and guidelines from other regulatory agencies for the management of clinical trials within the US/EU and other regions, as appropriate.
Assist in the review and revision of Clinical Development and QA SOPs.
Conduct GCP training for client's staff.
Alert QA GCP Management of internal and external GCP compliance and clinical trial issues in a timely manner.
Assist in risk identification and suggest mitigation plans related to assigned projects.
Become thoroughly familiar with assigned client compounds and protocols.
Provide support for regulatory authority inspections including conducting pre-inspection audits of sites, CRO?s and processes.
Assist with the management of QA consultants performing audits on behalf of client.
Minimum Requirements:
Bachelor?s degree
5 ? 10 years? experience in a pharmaceutical or bio-pharmaceutical company with a minimum of 5 years? experience in a GCP QA role conducting audits of CRO?s and investigator sites.
Ability to travel up to 30%.
Strong written and oral communication skills.
Prior Regulatory inspection experience preferred.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
GCP: 5 years
Regulatory Inspection: 5 years
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