GCP QA Consultant

Walker Cole International is supporting a European-based biotech, advancing a pipeline of early-phase study. As part of continued growth and clinical development activities, we are recruiting a GCP QA Consultant to provide quality oversight across ongoing and upcoming clinical trials.

This role will play a key part in ensuring GCP compliance within a fast-paced biotech environment, supporting early to late-phase clinical studies, vendor oversight, and inspection readiness.

Key responsibilities:

• Plan, conduct, and report GCP audits (investigator sites, CROs, and vendors)
• Ensure clinical trials are conducted in compliance with ICH-GCP, protocols, SOPs, and regulatory requirements
• Support quality oversight of outsourced clinical activities, including CRO and vendor management
• Identify quality risks and non-compliance issues, and lead CAPA development and tracking
• Drive inspection readiness activities, including preparation for regulatory authority inspections
• Review and develop SOPs and quality documentation aligned with a growing biotech environment
• Provide GCP guidance and training to internal teams and external partners
• Collaborate cross-functionally with Clinical Operations, Regulatory, and external stakeholders
• Support the implementation and continuous improvement of the Quality Management System (QMS)
• Operate independently, managing audit plans, priorities, and deliverables

Required experience and skills:

• Proven experience in GCP Quality Assurance within a biotech, pharmaceutical, or CRO environment
• Strong knowledge of ICH-GCP guidelines and global regulatory requirements
• Experience auditing CROs, vendors, and clinical trial sites
• Familiarity with outsourced/virtual operating models commonly used in biotech organisations
• Experience with CAPA management, risk-based quality approaches, and inspection readiness
• Ability to work in a fast-paced, evolving environment with changing priorities
• Strong stakeholder management and communication skills
• Ability to work autonomously in a contract role

Location: The Netherlands (Hybrid – travel to sites/vendors as required)
Contract length: 6-month contract
Rate: Competitive day rate
Working pattern: Flexible, hybrid

Clinical QA | GCP QA | Biotech | Good Clinical Practice | ICH-GCP | Quality Assurance | Clinical Trials | CRO Oversight | Vendor Audits | Regulatory Compliance | CAPA | QMS | Inspection Readiness | Risk Management | Life Sciences | Contract | Contractor