QA GxP Auditor

A biotechnology firm is seeking a GxP Auditor to lead vendor qualification audits and support inspection readiness activities. The position is part of the QA function and supports compliance across GMP, GLP, GCP, and other applicable quality systems.

Responsibilities

Conduct vendor, internal system, and clinical site audits.

Issue audit reports and manage audit follow-ups.

Track quality metrics and report compliance trends.

Support CAPA resolution, SOP development, and quality events.

Collaborate with vendor management to resolve compliance risks.

Maintain audit documentation in electronic systems (e.g., Veeva).

Requirements

Bachelor’s degree in a scientific discipline.

5+ years of GxP auditing experience in the biopharma industry.

Strong working knowledge of GMP / GLP / GCP / GVP and ICH / FDA / EU regulations.

Familiarity with CSV and data integrity principles is a plus.

Willingness to travel domestically and internationally.