GCP Auditor (Clinical Research)

TL;DR

GCP Auditor (Clinical Research): Supporting the audit program and clinical projects to ensure compliance with global regulations with an accent on GCP, ICH, and FDA standards. Focus on conducting internal, vendor, and investigator site audits to identify compliance risks and manage corrective actions.

Location: Remote, Spain

Company

hirify.global is a global Clinical Research Organisation (CRO) focusing on precision medicine, rare diseases, and oncology.

What you will do

• Support the Quality Management System, including SOPs, training, and CAPA processes.
• Host client/sponsor audits and support regulatory inspections.
• Coordinate and conduct audits for internal quality systems, potential/contracted vendors, investigator sites, and Trial Master Files.
• Provide QA consultation and support to internal and external project teams.
• Participate in computer systems validation projects and systems change control processes.
• Monitor quality systems to provide feedback on compliance risks to QA management.

Requirements

• Must be based in Spain.
• Extensive working knowledge of managing audits in a Clinical Trials environment (GCP, CRO process, and Vendor audits).
• Working knowledge of GCP/ICH guidelines and FDA regulations and standards.
• Bachelor’s degree in science, healthcare, or a related field.
• Availability to travel up to 25% domestically and/or internationally.

Nice to have

• 2 or more years of experience in a QA GCP department within a related industry.
• QA certification (e.g., CQA, SQA).
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePRO).

Culture & Benefits

• Environment where employees feel appreciated for their daily contributions.
• Culture of valuing and nurturing employee ideas to impact positive change.
• Commitment to being an Equal Opportunity Employer.