GCP Auditor – Freelance

This is a fully remote position, open to applicants in New Zealand, +1 more country.

📋 Description

• Plan, prepare, execute, report, and follow up on various types of GCP audits in alignment with expected quality and timelines.

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

• Carry out GCP quality assurance projects for pharmaceutical and biotechnology client companies.

• Lead both internal and external GCP audits.

• Conduct audits of service providers and GCP systems.

• Organize and oversee inspection preparation activities for GCP process inspections at sponsor and investigator sites.

⛳️ Requirements

• A Bachelor's degree in Life Sciences is preferred.

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

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

• Experience in executing GCP systems audits.

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

• Extensive knowledge of national and international GCP legislation and guidelines.

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

• Capability to conduct remote audits.

🏝️ Benefits

• Up to 40% travel.

• Opportunity to conduct remote audits.

• A supportive and collaborative work environment.

• Encouragement for professional growth.

• Chance to make a significant impact across the life sciences industry.

• Work alongside a collaborative team of experts in clinical research, pharmacovigilance, and quality consulting.