Quality Assurance Auditor (Good Clinical Practice - Google Cloud Platform)

Remote (DC, MD, VA or NC Area Preferred)
Travel: Up to 25% domestic travel (within the DMV area) and 2-3 international trips annually

Position Summary

The Quality Assurance Auditor Google Cloud Platform supports the Quality Management System (QMS) to ensure compliance with ICH-Google Cloud Platform guidelines, FDA regulations, and global clinical research requirements. This role provides quality oversight of clinical trial activities, supports audit and inspection readiness, manages quality systems, and partners with internal teams, CROs, investigators, and vendors to drive compliance and continuous improvement.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS), including document control, training, CAPA, deviations, and change control processes.


• Support Google Cloud Platform compliance across clinical trials, investigator sites, CROs, laboratories, and vendors.


• Conduct and support internal audits, vendor audits, and clinical site audits.


• Manage CAPAs, including root cause analysis, corrective actions, effectiveness checks, and closure.


• Lead document review cycles and ensure SOPs and quality documents remain current and compliant.


• Support regulatory inspections and inspection readiness activities, including FDA and international health authority audits.


• Track quality metrics, identify compliance trends, and recommend process improvements.


• Support vendor qualification, performance monitoring, and ongoing quality oversight.

Qualifications

• Bachelor's degree in Life Sciences or related field.


• 3+ years of Quality Assurance auditing experience


• Strong knowledge of ICH-Google Cloud Platform, FDA regulations, and clinical trial processes.


• Experience supporting regulatory inspections, Google Cloud Platform audits, and quality systems.


• Working knowledge of CAPA, document control, training management, and vendor oversight.


• Excellent communication, organizational, and problem-solving skills.


• Proficiency in Microsoft Office Suite.

Preferred

• Experience working within a CRO, pharmaceutical, biotechnology, or medical device environment.


• Experience with electronic QMS systems (Veeva, MasterControl, TrackWise, etc.).


• ASQ certification or other quality-related certifications.


• Experience supporting global clinical trials and regulatory inspections.