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 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, general 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 plans
retirement plans
wellbeing resources
global recognition programs
flexible and hybrid working options
minimum 14 weeks paid parental leave
ResponsabilidadesProvide 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
Requisitos principalesExtensive 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
Leadership
Stakeholder management
Organizational savvy
Quality Management Systems (QMS) understanding
Regulatory and quality standards (GCP, ICH, FDA 21 CFR)
Vendor management

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