Senior GCP Auditor/Compliance Specialist

ZP Group•Bethesda, MD

55d•$75,000 - $110,000•Remote

About The Position

Piper Companies is hiring a Senior GCP Auditor/Compliance Specialist to support quality assurance within a clinical research team based in the Montgomery County area. This full-time 100% remote position involves occasional domestic and international travel for site audits (15-20% travel). The ideal candidate thrives in a fast-paced, collaborative environment and is dedicated to maintaining compliance with Good Clinical Practice (GCP) guidelines and regulatory standards throughout clinical trial operations. CANDIDATES MUST HAVE INDEPENDENTLY LED AUDITS IN A CLINICAL ENVIRONMENT. Any experience limited to audit participation, audit readiness, or GLP audits alone will NOT be considered.

Requirements

Bachelor's degree required.
Demonstrated experience in clinical site GCP auditing is essential (candidates must have GCP experience; GMP/GLP-only backgrounds are not sufficient).
Understanding of regulatory audit processes and quality systems within Contract Research Organizations (CROs).
Solid grasp of current GCP regulations.
Strong communication skills, both written and verbal.
Proficiency in Microsoft Office applications.

Responsibilities

Lead audits of clinical trial sites to ensure adherence to Good Clinical Practice (GCP) guidelines.
Contribute to the development and maintenance of the Quality Management System (QMS).
Oversee QA functions including training programs, document control, customer complaint handling, and CAPA processes.
Lead internal audits and help drive continuous improvement through performance metrics.
Review and update QA-controlled documentation to ensure alignment with current procedures.
Assist in audits of vendors and suppliers and provide support during regulatory inspections.