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La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.
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 mana

📌 Senior Quality Assurance Lead (Barcelona)
🏢 Solutia
📍 Barcelona