Senior Quality Assurance Lead - GCP Expert Senior Quality Assurance Lead - GCP Expert Get AI-powered advice on this job and more exclusive features.

Solutia Life

Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors. We are currently looking for a Senior QA specialized in GCP's for clinical-stage biotech company, located in Barcelona.

The Quality Assurance

Manager will lead and oversee all aspects of the Quality Management System (QMS) to ensure compliance with regulatory requirements (e.g., The position requires close collaboration with various departments to implement quality assurance systems, conduct audits, and drive improvements. It is essential for maintaining the integrity of clinical data. Improve and maintain the Quality Management System (QMS) in compliance with applicable regulations and standards.

Develop, implement and maintain a Quality Risk Management (QRM) process to identify, assess, control, communicate, mitigate and review risks according to standards and regulatory requirements. Support the development, review and approval of quality-related documentation, including SOPs, batch records, and validation protocols. Manage CAPA (Corrective and Preventive Actions), deviations, change control, and risk management processes.

Oversee document control, training programs, and quality metrics reporting. Review and approve clinical trial documentation, including protocols, informed consent forms, monitoring plans, and clinical study reports. Collaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Data Management to ensure quality is embedded across all clinical activities.





Provide expert QA guidance and oversight to clinical development teams and functions (e.g., Educating clinical staff on regulatory requirements, quality standards and good practices. Collaborate in GxP training activities across the organization. Collaborate with R&D;, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality is integrated throughout the product lifecycle.

Bachelor's or Master's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related field.

Certification in quality assurance or a related field. Minimum 6 years of experience in clinical quality assurance in the biotech, pharmaceutical, or CRO industry. In-depth knowledge of ICH-GCP, EMA and FDA regulations, and global clinical trial processes and requirements. Ability to interpret regulations and provide pragmatic, risk-based QA guidance. Familiarity with Quality Risk Management (QRM) approach Strong understanding of clinical trial documentation and data integrity principles.

Fixed Contract

Hybrid position – 3 days Office – 2 days Home Adaptable entry hours Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Project Management and Quality Assurance Get notified about new Quality Expert jobs in Barcelona, Catalonia, Spain .

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📌 Senior Quality Assurance Lead - GCP Expert (Barcelona)
🏢 Solutia
📍 Barcelona