Descripción de la oferta
ppbSolutia Life Sciences (recruitment division of Solutia) specializes in technical and middle management profiles in the pharmaceutical, biotech, and medical device sectors. /b /ppWe are currently looking for a bSenior /b bQA specialized in GCP's /bfor clinical-stage biotech company, located in bBarcelona. /b /ph3Purpose of the job: /h3pThe 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. /ppThe 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. /ph3Major accountabilities /h3ulliImprove and maintain the Quality Management System (QMS) in compliance with applicable regulations and standards. /liliDevelop, implement and maintain a Quality Risk Management (QRM) process to identify, assess, control, communicate, mitigate and review risks according to standards and regulatory requirements. /liliDevelop, implement and maintain the clinical audit program based on risk assessment /lilibEnsure adherence to Good Clinical Practice (GCP) guidelines. /b /liliSupport the development, review and approval of quality-related documentation, including SOPs, batch records, and validation protocols. /liliLead internal and external audits (investigator sites, CROs, vendors, TMFs, internal Systems, etc.). /liliSupport regulatory inspections (FDA, EMA), including preparation, hosting, CAPA responses, and follow-up. /liliManage CAPA (Corrective and Preventive Actions), deviations, change control, and risk management processes. /liliOversee document control, training programs, and quality metrics reporting. /liliReview and approve clinical trial documentation, including protocols, informed consent forms, monitoring plans, and clinical study reports. /liliCollaborate with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Data Management to ensure quality is embedded across all clinical activities. /liliProvide expert QA guidance and oversight to clinical development teams and functions (e.g., Clinical Operations, Pharmacovigilance, Medical Affairs). /liliEducating clinical staff on regulatory requirements, quality standards and good practices. /liliCollaborate in GxP training activities across the organization. /liliStay current with evolving GCP regulatory requirements and interpret their impact on internal processes and trials. /liliCollaborate with RD, Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality is integrated throughout the product lifecycle. /li /ulh3Requirements: /h3ulliBachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related field. /liliCertification in quality assurance or a related field. /liliMinimum 6 years of experience in clinical quality assurance in the biotech, pharmaceutical, or CRO industry. /liliIn-depth knowledge of ICH-GCP, EMA and FDA regulations, and global clinical trial processes and requirements. /liliAbility to interpret regulations and provide pragmatic, risk-based QA guidance. /liliFamiliarity with Quality Risk Management (QRM) approach /liliStrong experience conducting GCP audits (sites, Systems, vendors, TMFs) and managing regulatory inspections. /liliStrong understanding of clinical trial documentation and data integrity principles. /liliExcellent analytical and problem-solving skills. /liliEffective communication and interpersonal skills. /liliStrong organizational skills; ability to manage multiple priorities, attention to detail. /liliAbility to work independently and as part of a team. /li /ulh3They offer: /h3ulliFixed Contract /liliHybrid position – 3 days Office – 2 days Home /li /ul /p #J-18808-Ljbffr
