Experteer Overview In 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 GxP 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 / Beneficios • Provide QA oversight for technology-enabled third-party qualifications and governance as a SME in digital/innovation contexts • Assist in risk identification for new third parties for GxP and rapid ramp-up scenarios • Support trial teams to assess technology fit for purpose based on study design • Review and approve quality issues related to third parties and escalate major/critical issues • Support breach assessment and health authority reporting • Facilitate Quality with Technology discussions to improve collaboration with third-party management • Act as QA representative for cross-functional digital technology initiatives and third-party quality activities • Participate in independent reviews of technology implementations for inspection readiness and data integrity • Ensure outsourcing-related inspection readiness and support audits and HA inspections for third-party management Responsabilidades • Extensive experience in pharmaceutical development and vendor management • Bachelor in Life Sciences, Pharmacy or Medicine; advanced degrees in IT/Engineering/Scientific disciplines or Ph.D. preferred • Fluent English (spoken and written) • Knowledge of GCP/GcLP, GVP, Medical Device regulations • Experience with clinical third-party management • SDLC-based computer system compliance and validation in pharma or digital health tech • Knowledge of GCP, ICH, FDA 21 CFR Part *, ISO • Experience in implementing DHT/SaMD technology in clinical trials • Ability to work in a global, matrixed environment and drive cross-functional projects Requisitos principales • insurance plans • retirement plans • wellbeing resources • integral recognition programs • flexible and hybrid working options • minimum 14 weeks paid parental leave

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