GCP Consultant

Summary

Join ADAMAS, a leading provider of regulatory compliance and consulting services to the pharmaceutical industry, as a GCP auditor. Plan, prepare, conduct, report, and follow up on various GCP audits, ensuring adherence to quality standards and timelines. Execute audits based on a comprehensive understanding of regulatory requirements and GCP. Perform GCP quality assurance projects for clients in the pharmaceutical/biotechnology industry. Assist with business development activities. ADAMAS offers a competitive salary with benefits, excellent working conditions, and opportunities for professional development. The company prioritizes diversity, equity, and inclusion, fostering a supportive and collaborative work environment.

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
• Expert knowledge of national and international GCP legislation and guidelines
• Up to 40% travel and ability to conduct remote audits

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

Preferred Qualifications

• Experience in conducting GCP mock inspections to Competent Authority standard considered a significant advantage
• Multilingual is an advantage

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