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

- 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 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 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/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 11/820, ISO 13485
- 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