Overview

In this role, you will strengthen vendor operations for regulatory inspections and audits within Global Clinical Operations. You will bring subject-matter expertise to inspection readiness, audit support, CAPA, and vendor compliance across general partnerships. By leveraging compliance data and trends, you’ll drive risk reduction and process improvements to meet Novartis standards. You’ll collaborate with cross-functional teams to embed regulatory excellence and effective communications, while shaping how we prepare for inspections and ensure high-quality vendor performance.

Compensaciones / Beneficios

- insurance plans
- retirement plans
- wellbeing resources
- global recognition programs
- flexible and hybrid working
- minimum 14 weeks paid parental leave

Responsabilidades

- Develop and implement vendor operations standards, processes, and governance frameworks
- Lead inspection readiness and support regulatory inspection activities across vendor partnerships
- Ensure consistent vendor risk assessment, selection, and compliance processes
- Oversee vendor quality metrics, identify trends and improvement opportunities
- Develop templates, tools, and resources for vendor governance and compliance
- Support audit planning, preparation, and follow-up, including CAPA management




- Act as a subject-matter expert on vendor compliance and quality management
- Partner with global and local stakeholders to strengthen operational consistency and regulatory compliance
- Drive continuous improvement to enhance vendor performance and inspection readiness
- Deliver training and communications to support adoption of systems and compliance requirements

Requisitos principales

- University degree in business or relevant field, or equivalent professional experience
- Typically 8-10+ years’ experience in clinical operations, including systems, regulatory requirements, and third-party/vendor management
- Strong knowledge of GCP and GxP regulations (ICH)
- Demonstrated experience supporting/regulatory inspections and managing back-room activities
- Experience with inspection readiness, evidence collection, and regulatory document requests
- Experience supporting audits and developing/managing CAPAs
- Strong understanding of clinical trial design, vendor compliance, and third-party requirements
- Proven global matrix leadership, independent ownership, analytical decision-making, and diplomatic stakeholder influence

- diplomatic stakeholder influence
- analytical decision-making
- cross-functional collaboration
- GCP
- GxP compliance
- GxP regulations

📌 Vendor Operations Lead - Global Clinical Operations (GCO) (Barcelona)
🏢 Novartis
📍 Barcelona