Piper Companies
Senior CGP Auditor
Piper Companies, Boston, Massachusetts, us, 02298
Piper Health and Sciences is actively seeking a Senior GCP Auditor with proven knowledge of GCP across all phases of Clinical Research. The Senior GCP Auditor will plan and conduct internal and external audits including system audits, supplier audits, safety/pharmacovigilance (PV) audits and others. The Senior GCP Auditor r is a remote, full time opportunity with travel requirements for in-person audit activities.
Responsibilities of the Senior GCP Auditor :
Perform GxP audits related to clinical research (investigator site audits, TMF audits, CRF audits, database audits, For-cause audits, supplier audits, regulatory inspection, etc.)Provide advice on regulatory compliance to internal and external partners regarding implementation of GxP and safety/PV requirementsReview and gather responses to audit observations and escalate priority responses to ensure timelines are metEngage in client meetings and ensure audits are delivered in accordance to clients' requirements and internal proceduresFacilitate client audits and regulatory inspectionsQualifications of the Senior GCP Auditor :
5 - 9 years of experience in quality assurance, regulatory, and/or auditing as it relates to clinical researchUnderstanding of national and international laws related to clinical trialsExperience conducting internal and external GCP auditsAbility to travel up to 60%Compensation of the Senior GCP Auditor:
$110,000 - $150,000 base + bonus, depending on relevant years of industry experienceFull comprehensive benefits package
#LI-SR1
Responsibilities of the Senior GCP Auditor :
Perform GxP audits related to clinical research (investigator site audits, TMF audits, CRF audits, database audits, For-cause audits, supplier audits, regulatory inspection, etc.)Provide advice on regulatory compliance to internal and external partners regarding implementation of GxP and safety/PV requirementsReview and gather responses to audit observations and escalate priority responses to ensure timelines are metEngage in client meetings and ensure audits are delivered in accordance to clients' requirements and internal proceduresFacilitate client audits and regulatory inspectionsQualifications of the Senior GCP Auditor :
5 - 9 years of experience in quality assurance, regulatory, and/or auditing as it relates to clinical researchUnderstanding of national and international laws related to clinical trialsExperience conducting internal and external GCP auditsAbility to travel up to 60%Compensation of the Senior GCP Auditor:
$110,000 - $150,000 base + bonus, depending on relevant years of industry experienceFull comprehensive benefits package
#LI-SR1