GCP Auditor (Freelance)

About the role

Ergomed is seeking a freelance GCP Auditor to plan, execute and report on Good Clinical Practice audits for pharmaceutical and biotechnology clients. The role involves both on‑site and remote audit activities with significant travel.

Key responsibilities

• Plan, prepare, conduct, report and follow‑up on various GCP audits according to quality standards and timelines.
• Execute audits based on a comprehensive understanding of regulatory requirements and GCP guidelines.
• Perform GCP quality‑assurance projects for client companies.
• Coordinate inspection preparation activities for sponsor and investigator sites.
• Conduct GCP mock inspections to Competent Authority standards where applicable.

Required profile

• BSc in Life Science (preferred).
• Proven experience leading internal and external GCP audits for diverse stakeholders.
• Experience auditing service providers such as CROs, biostatistics, data management and phase‑I sites.
• Experience with GCP systems audits and inspection preparation.
• Expert knowledge of national and international GCP legislation and guidelines.
• Willingness to travel up to 40% and conduct remote audits.

Required skills

• Deep understanding of GCP regulatory frameworks.
• Ability to conduct remote audits using appropriate tools.