Remote & Travel‑Ready GCP Auditor

Ergomed; California (MO); On-site; USD 90,000 - 140,000; Full time

Job summary

Ergomed Group is seeking a skilled GCP Auditor to support the execution of comprehensive GCP audits across the pharmaceutical and biotechnology sectors. The role involves planning, conducting, and reporting audits, with emphasis on regulatory compliance and patient safety.

The ideal candidate will bring extensive experience in internal and external GCP audits, comfort with service-provider audits, and the ability to coordinate inspection preparation at sponsor or investigator sites.

Qualifications

• 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.
• 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.
• Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site.
• Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage.
• 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.

Skills

GCP audits

Auditing

Regulatory knowledge

Remote audits

Travel flexibility

Education

BSc in Life Science

Job description

Ergomed Group is seeking a skilled GCP Auditor to support the execution of comprehensive GCP audits across the pharmaceutical and biotechnology sectors. The role involves planning, conducting, and reporting audits, with emphasis on regulatory compliance and patient safety.

The ideal candidate will bring extensive experience in internal and external GCP audits, comfort with service-provider audits, and the ability to coordinate inspection preparation at sponsor or investigator sites.