Descripción de la oferta
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 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.Develop, implement and maintain the clinical audit program based on risk assessmentEnsure 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 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., Clinical Operations, Pharmacovigilance, Medical Affairs).Educating clinical staff on regulatory requirements, quality standards and good practices.Collaborate in GxP training activities across the organization.Stay current with evolving GCP regulatory requirements and interpret their impact on internal processes and trials.Collaborate with R&D, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality is integrated throughout the product lifecycle.Requirements: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) approachStrong experience conducting GCP audits (sites, Systems, vendors, TMFs) and managing regulatory inspections.Strong understanding of clinical trial documentation and data integrity principles.Excellent analytical and problem-solving skills.Effective communication and interpersonal skills.Strong organizational skills; ability to managemultiple priorities, attention to detail.Ability to work independently and as part of a team.They offer:Fixed ContractHybrid position – 3 days Office – 2 days Home#J-18808-Ljbffr
