Specialist, Quality Assurance GCP

Experteer Overview In this role you will support the Clinical Quality Management System to ensure ICH-GCP compliance across sponsor-led trials (Phase II–IV). You will provide operational QA oversight, drive risk-based quality activities, and support outsourced activities with CROs and vendors. You will contribute to inspection readiness and CAPA management, while coaching cross-functional teams in GCP and quality practices. This position offers a meaningful chance to shape clinical quality processes and strengthen the organization’s compliance culture.
Retribuzione / Benefits   Develop, maintain and improve the Clinical Quality Management System, including SOPs, work instructions and templates
Conduct quality oversight activities: study-level and system-level audits, vendor/CRO audits and qualifications
Participate in risk-based quality activities including risk assessments and audit planning
Oversee outsourced clinical activities ensuring CROs/vendors comply with ICH GCP and contractual obligations
Manage deviations, CAPAs and quality issues with root cause analysis and effectiveness checks
Support inspection readiness activities: documentation preparation, mock inspections, follow-up actions
Assist regulatory inspections and health authority audits as part of Sponsor QA team
Provide GCP guidance to Clinical Operations, Clinical Development and cross-functional teams
Support delivery of GCP training and quality awareness initiatives
Contribute to continuous improvement initiatives to enhance efficiency, compliance and quality culture
Responsabilità   4–6 years of experience in Clinical Quality Assurance, Clinical Operations, or related GxP functions
Hands‑on experience supporting Phase II–IV trials

Experience with CROs and external vendors
Exposure to regulatory inspections or Sponsor audits is preferred
Strong knowledge of ICH GCP guidelines and global clinical trial regulations
Understanding of sponsor responsibilities in outsourced clinical trials
Familiarity with quality systems, audit processes, and CAPA management
Ability to apply a risk‑based approach to quality oversight

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