Remote GCP Consultant

Summary

Join ADAMAS, a leading provider of regulatory compliance and consulting services, as a GCP Auditor to conduct audits, lead quality assurance projects, and assist with business development activities.

Requirements

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

Responsibilities

• Planning, preparation, conduct, reporting and follow up of various types of GCP audits according to expected quality and timelines
• Executing audits based on a comprehensive understanding of all regulatory requirements and Good Clinical Practice (GCP)
• Performing GCP quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry
• Assisting with business development activities

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language