Senior GCP Process Auditor

Precision For Medicine

GCP Process Auditor supporting clinical trial compliance and audit programs at Precision for Medicine. Ensuring adherence to regulations and procedures throughout clinical studies.

Posted 7/3/2026full-timeRemote • 🇷🇴 RomaniaSeniorWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Maintains 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

The ideal candidate will have extensive, working knowledge of managing all types of Audits, particularly GCP Process Audits - candidates without this experience cannot, unfortunately, be considered
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
CROexperience
QA certification preferred (e.g., CQA, SQA, etc.)
Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO, etc.)

Benefits

Comp & perks

Competitive salary
Flexible working hours
Professional development budget
Home office setup allowance
Global team events

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management SystemAudit ManagementDocumentation ControlTraining DevelopmentCorrective And Preventive ActionsCompliance MonitoringQuality Assurance ConsultationInternal AuditsTrial Master File AuditsComputer Systems Validation

Certifications

CQASQA