Senior GCP Auditor - Lead Inspections & Compliance

Ergomed; Argentina; On-site; ARS 900,000 - 1,500,000; Full time

Job summary

Ergomed is seeking a GCP Auditor to lead and coordinate audits across sponsor and investigator sites. You will ensure compliance with national and international GCP regulations and perform quality assurance projects for pharmaceutical clients.

The role requires extensive audit experience, travel up to 40%, and the ability to conduct remote audits as needed. A Life Science background supports understanding regulatory expectations in biopharma.

Qualifications

• Experience in conducting and leading internal and external GCP audits for a variety of stakeholders.
• Experience in conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I).
• Experience in conducting GCP systems audits.
• Expert knowledge of national and international GCP legislation and guidelines.
• Up to 40% travel and ability to conduct remote audits.

Responsibilities

• Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines.
• Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP).
• Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.
• Coordinating and managing inspection preparation activities for GCP process inspections at sponsor and investigator sites.
• Performing GCP mock inspections to Competent Authority standards.

Skills

GCP audits

Audit planning

Regulatory compliance

Quality assurance

Travel up to 40%

Remote audits

Education

BSc in Life Science

Job description

Ergomed is seeking a GCP Auditor to lead and coordinate audits across sponsor and investigator sites. You will ensure compliance with national and international GCP regulations and perform quality assurance projects for pharmaceutical clients.

The role requires extensive audit experience, travel up to 40%, and the ability to conduct remote audits as needed. A Life Science background supports understanding regulatory expectations in biopharma.