13 ago
|
Eblex Group
|
Comunidad de Madrid
13 ago
Eblex Group
Comunidad de Madrid
Eblex Group
is supporting an innovative
biotechnology company
in Spain to appoint an experienced
GCP Consultant
to provide quality oversight across its clinical development programmes.
This is an excellent opportunity to work with a growing biotech, ensuring clinical studies are conducted in compliance with
ICH-GCP, EU Clinical Trial Regulation, and EMA requirements
, while supporting inspection readiness and quality management activities.
Key Responsibilities
• Provide GCP quality oversight across Phase I–III clinical trials
• Support GCP audits, CAPAs, and quality investigations
• Ensure compliance with ICH-GCP, EU CTR, and company SOPs
• Review clinical trial documentation and Trial Master Files (TMFs)
• Partner with Clinical Operations, Regulatory Affairs, Medical, and external CROs
• Support inspection readiness and continuous quality improvement initiatives
Requirements
- 5+ years' experience in GCP Quality Assurance or Clinical Quality within biotech, pharma, or CRO environments
- Strong knowledge of
ICH-GCP, EU Clinical Trial Regulation, and EMA guidance
- Experience supporting clinical trials and regulatory inspections
- Previous biotech experience preferred
- Fluent English required. Spanish is a plus
Eblex Group
is managing this search exclusively. Apply or contact us for a confidential discussion.
GCP | GCP Consultant | Clinical Operations | Biotech | Clinical Quality | ICH | ICH-GCP | Audit | CAPA | Clinical | Quality Assurance | Quality | QA
📌 Clinical Quality Consultant (Comunidad de Madrid)
🏢 Eblex Group
📍 Comunidad de Madrid