GCP Auditor; Homebased

Job Description

The GCP Auditor supports and strengthens the Quality Management System by leading and participating in Good Clinical Practice (GCP) audits and related quality assurance activities. This role maintains core quality programs, including QA training, document control, customer complaint handling, and CAPA, while ensuring compliance with current GCP regulations and regulatory expectations. The position offers the opportunity to grow within an organization that prioritizes internal promotion and provides a fully remote work arrangement with travel for audits as required.

• Support the maintenance and continual improvement of the Quality Management System to ensure compliance with current GCP regulations and internal procedures.
• Maintain and administer the Quality Assurance training program to ensure personnel receive appropriate and timely GCP and QA training.
• Manage document control activities, including creation, revision, distribution, and archiving of QA‑controlled documents, to ensure practices reflect written procedures.
• Maintain and support the customer complaint program, ensuring complaints are documented, investigated, and resolved in alignment with quality and regulatory requirements.
• Support and maintain the Corrective and Preventive Action (CAPA) program, including initiation, tracking, and verification of effectiveness of CAPAs.
• Plan, conduct, and support audits of clinical sites to assess adherence to GCP, protocols, and applicable regulations.
• Plan, conduct, and support audits of vendors and suppliers, including CROs, to evaluate their Quality Systems and GCP compliance.
• Support the internal audit program by planning, performing, and reporting on internal audits across relevant functions.
• Support the performance metrics system for continual improvement by collecting, analyzing, and reporting quality and audit‑related metrics.
• Manage the review cycle of QA‑controlled documents to ensure timely updates and alignment of operational practices with written procedures.
• Support regulatory agency audits and inspections by preparing documentation, coordinating responses, and participating in inspection activities.
• Collaborate with cross‑functional teams to address audit findings, implement corrective and preventive actions, and monitor completion.
• Prepare clear, concise, and accurate audit reports and quality documentation.
• Communicate audit results, quality issues, and process improvement recommendations effectively to stakeholders.
• Use MS Office tools to document audits, track quality metrics, and prepare presentations and reports.

• Minimum of 4 years of direct experience performing GCP internal, external, and site audits.
• Strong knowledge of current GCP regulations and guidelines.
• Experience working with regulatory agency audits and inspections.
• Experience working with Quality Systems for contract research organizations (CROs).
• Demonstrated experience conducting GCP internal audits.
• Demonstrated experience conducting GCP external audits, including vendor and supplier audits.
• Proficiency in MS Office applications for documentation, reporting, and communication.
• Excellent written and verbal communication skills for audit reporting and stakeholder interaction.
• Experience supporting or maintaining Quality Assurance programs such as QA training, document control, customer complaint handling, and CAPA.
• Ability and willingness to travel approximately 25% locally, domestically, and internationally for audits.

• Experience supporting or participating in regulatory inspections by various regulatory authorities.
• Background in GCP Quality Assurance roles with responsibility for internal, external, and site audits.
• Experience working with performance metrics systems for continual quality improvement.
• Ability to collaborate effectively with cross‑functional teams across a remote work environment.
• Strong organizational skills with the ability to manage multiple audits, document reviews, and quality initiatives simultaneously.
• Comfort working in a fully remote setting while maintaining responsiveness and clear communication.

This role…