Quality Assurance Gcp

ppPhidealive S.r.l. is an independent Italian full-service Contract Research Organization (CRO) operating as a Clinical Research Atelier. /p pUnlike large global CROs, we work through a selective, highly tailored model, combining scientific expertise, regulatory rigor and close operational involvement in every project. We partner with pharmaceutical and biotech companies, medical device developers and academic investigators to design and deliver clinical studies in Italy and internationally. /p pOur multidisciplinary team supports clinical development throughout the study lifecycle, from strategy and protocol design to regulatory activities, study start-up, project management, monitoring, data management, biostatistics and medical writing. /p pWe focus on projects where quality, reliability and scientific value are essential to generating meaningful evidence and advancing healthcare solutions. /p h3Role Description /h3 pPhidealive is seeking an experienced Quality Assurance professional with solid and demonstrable expertise in Good Clinical Practice (GCP) and clinical research. /p pThe successful candidate will support the oversight, maintenance and continuous improvement of Phidealive's Quality Management System and ensure that clinical activities are conducted in compliance with applicable regulations, internal procedures and sponsor requirements. /p h3Key responsibilities will include: /h3 ul liMaintaining and improving the Quality Management System, including SOPs, policies, templates and quality records; /li liPlanning, conducting and reporting internal audits, vendor audits, investigator site audits and study-specific audits; /li liReviewing clinical trial documentation and processes from a quality and compliance perspective; /li liManaging audit findings, deviations, root cause analyses and Corrective and Preventive Actions (CAPAs); /li liSupporting inspection readiness; /li liProviding quality oversight throughout the clinical study lifecycle; /li liAdvising Clinical Operations and other functions on GCP compliance and quality-related matters; /li liContributing to GCP and quality training for internal staff; /li /ul pThis is a hybrid position based in Milan. /p h3Essential Qualifications /h3 ul liAt least 5 years of professional experience in clinical research within a CRO, pharmaceutical, biotech or medical device organization; /li liDemonstrable experience in a Quality Assurance role specifically related to GCP-regulated clinical trials; /li liStrong knowledge of ICH-GCP, EU Clinical Trials Regulation (EU) No. 536/2014 and applicable Italian and European clinical research requirements; /li liHands-on experience in planning, conducting and documenting GCP audits; /li liExperience in Quality Management Systems, SOP management, deviations, root cause analysis and CAPA processes; /li liAbility to independently assess compliance risks and provide practical, proportionate guidance to clinical project teams; /li liExcellent analytical, organizational and communication skills; /li liProfessional proficiency in written and spoken English and Italian; /li liBachelor's or Master's degree in life sciences, pharmacy, medicine or another relevant scientific discipline. /li /ul h3Preferred Qualifications /h3 ul liPrevious experience in a CRO environment; /li liExperience supporting inspection-readiness activities; /li liKnowledge of ISO 14155 and quality requirements applicable to medical device clinical investigations; /li liExperience delivering GCP and quality training. /li /ul pPlease note that this position requires specific, hands-on Quality Assurance experience in GCP-regulated clinical research. Candidates without direct experience in GCP Quality Assurance will not be considered. /p pIf you are interested in joining an independent CRO where quality is an integral part of every project—not simply a final compliance check—we would be pleased to hear from you. /p pQuality Assurance GCP, Varese, Lombardy, Italy /p /p #J-18808-Ljbffr