GCP Quality Assurance Specialist

• University degree in Health Sciences or Life Sciences.
• We will especially value degrees in Pharmacy, although we will also consider profiles in Biotechnology, Medicine, Nursing, or other related disciplines.
• Between 3 and 6 years of experience in clinical quality, clinical operations, CROs, clinical trial sponsors, or GCP-related functions.
• Solid knowledge of ICH-GCP guidelines and essential clinical trial documentation.
• Experience in managing deviations, CAPA, SOPs, audits, or eTMF review.
• Professional level of English.

• Experience in biotechnology, pharmaceutical, or CRO companies.
• Participation in vendor oversight activities.
• Experience in preparation and support during regulatory inspections.
• Knowledge of Veeva or other document management and eTMF platforms.

Would you like to participate in innovative clinical projects within a growing biotechnology company?

At Biofabri, we are looking for a GCP QA Specialist to contribute to guaranteeing the quality and compliance of our clinical trials, collaborating with multidisciplinary teams and external organizations to ensure that studies are conducted in accordance with the highest regulatory and quality standards.

You will be a key piece in ensuring that our clinical trials are conducted in accordance with Good Clinical Practice (ICH-GCP), applicable regulatory requirements, and the highest quality standards.

You will work cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Quality Assurance teams, as well as collaborating with CROs and external providers, contributing to ensuring traceability, document integrity, and continuous readiness for audits and inspections.

Your main responsibilities will include:

• Develop, review, and maintain standard operating procedures (SOPs), templates, and clinical quality system documentation.
• Manage and monitor deviations, audits, and CAPA plans.
• Participate in GCP audits and in preparation activities for regulatory inspections.
• Review essential clinical trial documentation and ensure the quality and integrity of the eTMF.
• Perform monitoring and oversight activities for CROs and external providers.
• Maintain training records and matrices in Good Clinical Practice.
• Identify continuous improvement opportunities within the clinical quality system.

We are looking for someone who combines technical rigor with a global vision of clinical development.

An organized, detail-oriented person with a clear orientation toward regulatory compliance, capable of working collaboratively with multidisciplinary teams and driving a culture of quality in a dynamic and innovative environment.