GCP Consultant

Summary

Join ADAMAS, a leading provider of regulatory compliance and consulting services to the pharmaceutical industry, and independently oversee and manage multiple audit programs. Successfully lead and oversee external contractors, demonstrating excellence in project management through quality deliverables and compliance. Plan, prepare, conduct, report, and follow up on GCP audits, executing audits based on regulatory requirements and Good Clinical Practice (GCP). Perform GCP quality assurance projects and assist with business development activities. ADAMAS offers a competitive salary with benefits, excellent working conditions, and opportunities for further development. The company prioritizes diversity, equity, and inclusion, fostering a supportive and collaborative work environment.

Requirements

• Experience in coordinating and managing inspection preparation activities for GCP process inspections both at the sponsor and investigator site
• 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., investigator site audits, full-service CRO, phase I, Mock Inspections)
• Experience in conducting GCP systems audits
• Expert knowledge of national and international GCP legislation and guidelines
• Up to 40% travel and ability to conduct remote audits

Responsibilities

• Independently oversee and manage multiple audit programs while maintaining compliance with applicable processes and procedures
• Successful Leadership and oversight of external contractors with a dedication for building strong relationships
• Demonstrates Excellence in Project Management through the successful provision of quality deliverables; generation and maintenance of project governing documentation and plans; oversight of key performance indicators (KPIs) and Key Quality Indicators (KQIs); while maintaining compliance with contract requirements and financial agreements
• Resource and maintain the audit programs and schedules
• 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

• BSc in Life Science preferred
• Experience in conducting GCP mock inspections to Competent Authority standard considered a significant 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