GCP Auditor – Freelance

This is a fully remote position, open to applicants in California.

📋 Description

• Plan, prepare, execute, report, and follow-up on various types of GCP audits while adhering to expected quality standards and timelines.

• Conduct audits grounded in a thorough understanding of regulatory requirements and Good Clinical Practice (GCP).

• Carry out GCP quality assurance projects for clients in the pharmaceutical and biotechnology sectors.

• Lead and perform internal and external GCP audits for a variety of stakeholders.

• Execute audits for service providers and GCP systems.

• Organize and manage activities in preparation for GCP process inspections at both sponsor and investigator sites.

• Perform GCP mock inspections in accordance with Competent Authority standards.

⛳️ Requirements

• A BSc in Life Science is preferred.

• Proven experience in leading and conducting internal and external GCP audits for diverse stakeholders.

• Demonstrated experience in performing various service provider audits, including full-service CRO, biostatistics, data management, and phase I.

• Experience in conducting audits of GCP systems.

• Background in coordinating and managing preparation activities for GCP process inspections at sponsor and investigator sites.

• In-depth knowledge of national and international GCP legislation and guidelines.

• Capability to conduct remote audits.

• Willingness to travel up to 40% of the time.

🏝️ Benefits

• Up to 40% travel.

• A supportive and collaborative working environment.

• Encouragement for professional growth.

• An opportunity to create a significant impact within the life sciences sector.

• Collaboration with esteemed pharmaceutical and biotechnology organizations.

• A diverse and inclusive workplace where every voice is valued.