Clinical Quality Consultant (Comunidad de Madrid)

Clinical Quality Consultant (Comunidad de Madrid)

12 ago
|
Eblex Group
|
Comunidad de Madrid

12 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.

📌 Clinical Quality Consultant (Comunidad de Madrid)
🏢 Eblex Group
📍 Comunidad de Madrid

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