GCP Auditor (Freelance - West Coast USA)

Overview

This role supports pharmaceutical and biotechnology organizations with GCP (Good Clinical Practice) audit planning, execution, and follow-up, along with GCP quality assurance projects. Work includes independent, expertise-driven audit intelligence to identify compliance risks and help prevent issues that could put patients at risk.

Responsibilities

• Plan, prepare, conduct, report on, and follow up various types of GCP audits, in line with expected quality standards and timelines
• Execute GCP audits using a comprehensive understanding of all applicable regulatory requirements and Good Clinical Practice (GCP)
• Perform GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry

Requirements

• BSc in Life Science preferred
• Experience conducting and leading internal and external GCP audits for a variety of stakeholders
• Experience conducting a range of service provider audits (e.g., full-service CRO, biostatistics, data management, phase I)
• Experience conducting GCP systems audits
• Experience coordinating and managing inspection preparation activities for GCP process inspections at both the sponsor and investigator site
• Experience conducting GCP mock inspections to Competent Authority standard (considered a significant advantage)
• Expert knowledge of national and international GCP legislation and guidelines
• Ability to travel up to 40% and conduct remote audits

Compensation & Benefits

Not specified in the provided job description.