Senior Quality Assurance Lead - GCP Expert Senior Quality Assurance Lead - GCP Expert Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Solutia 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. Purpose of the job: The Quality Assurance Manager will lead and oversee all aspects of the Quality Management System (QMS) to ensure compliance with regulatory requirements (e.G., FDA, EMA, ICH) and internal standards. 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. Major accountabilities 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. Develop, implement and maintain the clinical audit program based on risk assessment Ensure adherence to Good Clinical Practice (GCP) guidelines. Support the development, review and approval of quality-related documentation, including SOPs, batch records, and validation protocols. Lead internal and external audits (investigator sites, CROs, vendors, TMFs, internal Systems, etc.). Support regulatory inspections (FDA, EMA), including preparation, hosting, CAPA responses, and follow-up. 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 conse

📌 Qa Lead (Les)
🏢 Adaptive
📍 Les