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 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 / Beneficios
insurance plans
retirement plans
wellbeing resources
global recognition programs
versátil and hybrid working options
minimum 14 weeks paid parental leave Responsabilidades
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 Gx P 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 principales
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/Gc LP, 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 11/820, ISO 13485
Experience in implementing DHT/Sa MD 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