Senior GCP Process Auditor

Precision For Medicine

GCP Process Auditor at Precision for Medicine supporting clinical projects. Ensuring compliance with regulations and providing expertise in quality and compliance activities.

Posted 7/3/2026full-timeRemote • 🇵🇱 PolandSeniorWebsite

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, supporting 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
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

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
Retirement plans
Paid time off
Flexible work arrangements
Professional development

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Audit CoordinationQuality AssuranceRegulatory Inspection SupportDocument ControlCAPA ManagementGCP/ICH GuidelinesFDA RegulationsInternal AuditsVendor AuditsComputer Systems Validation

Soft Skills

CommunicationCollaborationProblem-SolvingAttention to DetailTraining Facilitation