OverviewIn this role, you will guide QA for technology-enabled third parties across qualification, monitoring, and audits. You’ll partner with clinical trial teams and external vendors to ensure Gx P compliance and data integrity in a rapidly evolving digital health landscape. You will lead risk assessment, issue escalation, and inspection readiness, shaping how technology is integrated into trials. This is a cross-functional, global role that drives quality in innovative, tech-enabled clinical studies. You will be at the forefront of Quality with Technology, influencing collaboration and governance.Compensaciones / Beneficiosinsurance plansretirement planswellbeing resourcesglobal recognition programsflexible and hybrid working optionsminimum 14 weeks paid parental leave ResponsabilidadesProvide QA oversight for technology-enabled third-party qualifications and governance as a SME in digital/innovation contextsAssist in risk identification for new third parties for Gx P and rapid ramp-up scenariosSupport trial teams to assess technology fit for purpose based on study designReview and approve quality issues related to third parties and escalate major/critical issuesSupport breach assessment and health authority reportingFacilitate Quality with Technology discussions to improve collaboration with third-party managementAct as QA representative for cross-functional digital technology initiatives and third-party quality activitiesParticipate in independent reviews of technology implementations for inspection readiness and data integrityEnsure outsourcing-related inspection readiness and support audits and HA inspections for third-party management Requisitos principalesExtensive experience in pharmaceutical development and vendor managementBachelor in Life Sciences, Pharmacy or Medicine;

advanced degrees in IT/Engineering/Scientific disciplines or Ph. D. preferredFluent English (spoken and written)Knowledge of GCP/Gc LP, GVP, Medical Device regulationsExperience with clinical third-party managementSDLC-based computer system compliance and validation in pharma or digital health techKnowledge of GCP, ICH, FDA 21 CFR Part 11/820, ISO 13485Experience in implementing DHT/Sa MD technology in clinical trialsAbility to work in a general, matrixed environment and drive cross-functional projects LeadershipStakeholder managementOrganizational savvyQuality Management Systems (QMS) understandingRegulatory and quality standards (GCP, ICH, FDA 21 CFR)Vendor management

📌 Associate Director Esp Quality (Barcelona)
🏢 Novartis
📍 Barcelona