Senior GCP Process Auditor

Precision For Medicine

GCP Process Auditor supporting compliance in clinical projects for Precision for Medicine. Ensuring adherence to GCP guidelines and providing audit expertise during studies.

Posted 7/3/2026full-timeRemote • 🇷🇸 SerbiaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Support the audit program and clinical projects to ensure compliance with regulations and Precision procedures
Provide oversight and subject matter expertise to quality and compliance activities
Support project teams during all stages of a clinical study
Support the Quality Management System including SOPs, training and CAPA
Process and maintain documentation for controlled documents, as required
Develop and administer training for employees and/or consultants
Host client/sponsor audits and support regulatory inspections
Coordinate and conduct assessments of potential and contracted vendors, including vendor audits as warranted
Coordinate and conduct internal audits of quality systems
Coordinate and conduct investigator site audits
Coordinate and conduct trial master file audits
Participate on computer systems validation projects and systems change control process
Provide QA consultation and support to assigned project teams internally and externally
Support and manage reported quality issues and any associated corrective and preventive actions
Monitor quality systems to provide feedback on compliance risks to QA management and identify opportunities for improvement
Maintain Q&C trackers, databases, metrics, and files
Follow applicable regulations and standards, including but not limited to local regulations (US FDA and EU), ICH and company policies and procedures

Requirements

What you’ll need

Extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits
Working knowledge of GCP/ICH guidelines and FDA regulations and standards
Bachelor’s degree in a science, healthcare, or related field of study; combination of qualifications and equivalent relevant experience may be accepted as an alternative
Availability to travel up to 25% domestically and/or internationally

Benefits

Comp & perks

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Audit CoordinationQuality Assurance ConsultationDocument ControlTraining DevelopmentCompliance MonitoringCorrective and Preventive ActionsInternal AuditsVendor AuditsClinical Study SupportComputer Systems Validation

Soft Skills

CommunicationCollaborationProblem-SolvingAttention to DetailOrganizational Skills