GCP Auditor | Remote Audits & 40% Travel

ADAMAS Consulting; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

ADAMAS Consulting seeks a seasoned GCP audit professional to lead internal and external audits across the pharmaceutical/biotech space. You will plan, execute and report on audits, ensuring alignment with regulatory requirements and GCP guidelines.

The role involves coordinating inspection preparations, conducting remote audits when needed, and travel up to 40% to client sites or sponsor locations. Strong knowledge of global GCP legislation is essential.

Qualifications

• BSc in Life Science preferred.
• Experience in conducting and leading internal and external GCP audits for a variety of stakeholders.
• Experience in audits of service providers (e.g., CRO, biostatistics, data management, Phase I).
• Experience in conducting GCP systems audits.
• Experience coordinating inspection preparation activities for GCP inspections at sponsor and investigator sites.
• GCP mock inspections knowledge is a plus.
• Expert knowledge of national and international GCP legislation and guidelines.
• Willingness to travel up to 40% and conduct remote audits.

Responsibilities

• Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to quality standards and timelines.
• Executing audits based on regulatory requirements and Good Clinical Practice (GCP).
• Performing GCP quality assurance projects on behalf of client companies in the pharmaceutical/biotechnology industry.

Skills

GCP audits

Audit leadership

Regulatory knowledge

Remote audits

Travel readiness

Education

BSc in Life Science

Job description

ADAMAS Consulting seeks a seasoned GCP audit professional to lead internal and external audits across the pharmaceutical/biotech space. You will plan, execute and report on audits, ensuring alignment with regulatory requirements and GCP guidelines.

The role involves coordinating inspection preparations, conducting remote audits when needed, and travel up to 40% to client sites or sponsor locations. Strong knowledge of global GCP legislation is essential.