Senior Quality Assurance Lead - GCP ExpertJoin to apply for theSenior Quality Assurance Lead - GCP Expertrole atSolutia
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 aSenior QA specialized in GCPfor a clinical?stage biotech company, located inBarcelona.
Purpose of the jobThe 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.
Major accountabilitiesImprove 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?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., Educate 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.
RequirementsBachelor'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.
GCP, EMA and FDA regulations, and global clinical trial processes and requirements.
based QA guidance.
Familiarity with Quality Risk Management (QRM) approach.
Strong understanding of clinical trial documentation and data integrity principles.
BenefitsFixed contract.
Hybrid position – 3 days in office – 2 days home.
Adaptable entry hours.
Senior level.
Job functionProject Management and Quality Assurance.
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📌 Senior Quality Assurance Lead - Gcp Expert (Barcelona)
🏢 Solutia
📍 Barcelona