Clinical Quality Assurance Lead

SOLTI is an academic research group that performs clinical trials of excellence in oncology. Currently, SOLTI is comprised of over 550 renowned research professionals distributed over a broad network of more than 100 leading hospitals in Spain, Portugal, France and Ireland.

SOLTI focuses its efforts on developing cutting-edge clinical trials with novel targeted therapeutics including innovative translational research, fostering the participation in international networks and promoting excellence in the management of cancer among their members.

We are currently seeking a Clinical Quality Assurance Lead to oversee and execute all clinical quality assurance activities, ensuring strict compliance with Good Clinical Practice (GCP), applicable regulations and internal standards. This role is pivotal in reinforcing a culture of operational excellence and quality across our clinical studies.

As a key member of the organization, the Clinical Quality Assurance Lead will be responsible for:

- Operational Quality System Management: Oversee SOLTI’s electronic Quality Management System (Qualios), ensuring accuracy, compliance with ICH-GCP and regulatory standards and readiness for audits and inspections. Lead SOP updates and coordinate quality strategy across departments.
- CAPA Management & Quality Control: Drive corrective and preventive actions (CAPAs), monitor implementation and effectiveness and collaborate with teams to prevent deviations and foster continuous improvement.
- Audits & Inspections: Prepare for and lead internal audits, sponsor audits, regulatory inspections and quality reviews, ensuring proper documentation and closure of findings.
- TMF Oversight: Safeguard the integrity, completeness and audit-readiness of the Trial Master File (TMF) throughout the study lifecycle conducting periodic reviews and resolving discrepancies to ensure compliance and inspection readiness.
- Training & Competency Management: Design and deliver training programs on GCP, SOPs, compliance and eTMF processes. Ensure all programs remain up to date and properly documented, coordinate project-specific training sessions, update learning materials as needed and monitor adherence to compliance standards.
- Continuous Improvement: Identify opportunities to optimize processes, harmonize SOPs and templates and promote initiatives that strengthen a culture of quality across the organization.

This position offers the opportunity to shape and strengthen SOLTI’s quality-driven culture, ensuring that our clinical research consistently meets the highest standards of integrity and compliance.

Requirements:

- Bachelor’s degree in Health Sciences, Pharmacy, Biology, Biotechnology, Nursing or related fields.
- 3–5 years of experience in quality or monitoring within clinical research.
- Experience in CROs, academic groups, research centers or pharma sector.
- Proven expertise in QMS, CAPA management and GCP compliance.
- Advanced English (mandatory).
- Strong knowledge of ICH-GCP and regulatory frameworks.
- Experience with document management systems (Qualios or similar) and eTMF.
- Skilled in SOP drafting and audits.
- Detail-oriented, organized and proactive problem-solver.
- Excellent communication and training abilities.
- Team player with leadership skills and a continuous improvement mindset.

What we offer:

Explore the opportunity of joining an organization engaged in cutting-edge projects with significant social impact.

We offer a full-time position based in Barcelona with the possibility of working from home up to 3 days a week with a flexible work schedule and additional benefits.

If your background and experience align with the requirements of this position, we encourage you to apply and explore this exciting opportunity with us.

SOLTI is an employer committed to Equal Opportunities regardless of sex, gender, sexual orientation, race, age, origin or disability.

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