Senior GCP Process Auditor (Medical)

TL;DR

Senior GCP Process Auditor (Medical): Ensuring compliance with GCP/ICH guidelines and FDA regulations for clinical research projects with an accent on quality management systems and comprehensive audit execution. Focus on coordinating internal, vendor, and investigator site audits while managing CAPAs and supporting regulatory inspections.

Location: Remote, Slovakia

Company

hirify.global is a Clinical Research Organisation specializing in precision medicine for oncology and rare diseases.

What you will do

• Support the Quality Management System (QMS), including SOPs, training, and CAPA management.
• Conduct and coordinate internal audits, investigator site audits, and Trial Master File (TMF) audits.
• Perform assessments and audits of potential and contracted vendors.
• Host client/sponsor audits and provide support during regulatory inspections.
• Participate in computer systems validation projects and systems change control processes.
• Provide QA consultation and support to internal and external project teams.

Requirements

• Extensive working knowledge of GCP Process Audits is mandatory.
• Strong knowledge of GCP/ICH guidelines and FDA regulations/standards.
• Bachelor’s degree in science, healthcare, or a related field.
• Must be based in Slovakia.
• Availability to travel up to 25% domestically and internationally.

Nice to have

• Experience working within a Clinical Research Organisation (CRO).
• QA certification (e.g., CQA, SQA).
• Experience with electronic clinical trial systems (EDC, CTMS, IxRS, ePRO).

Culture & Benefits

• Work in a growing organization focused on ground-breaking cancer therapies.
• Environment where employee contributions are appreciated and ideas are valued.
• Opportunity to impact positive change within the company.
• Commitment to equal opportunity employment.