Vendor Operations Lead: Regulatory Readiness & Quality

Novartis; Barcelona; Híbrido; EUR 64.000 - 118.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work

On-site 12 days/month

Descripción de la vacante

Novartis in Barcelona seeks a senior vendor governance and compliance leader to drive standards across vendor operations, lead inspection readiness, and ensure regulatory compliance.

You will collaborate with global and local stakeholders, develop templates and tools, support audits, and manage corrective actions and documentation requests.

The role requires 8–10+ years in clinical operations, strong knowledge of GCP, GxP and ICH, and a proven track record in vendor management.

Formación

• University degree or equivalent experience in a relevant field.
• 8–10+ years in clinical operations including systems, regulatory requirements and vendor management.
• Strong knowledge of GCP, GxP and ICH.
• Experience supporting regulatory inspections and back-room activities.
• Experience with inspection readiness, evidence collection and regulatory document requests.
• Experience supporting supplier audits and corrective actions.

Responsabilidades

• Drive development and implementation of vendor operations standards, processes and governance frameworks.
• Lead inspection readiness and support regulatory inspection activities across vendor partnerships and operations.
• Ensure consistent vendor risk assessment, selection and compliance processes.
• Oversee vendor quality and compliance metrics, identifying trends and risks.
• Develop templates, tools and operational resources for vendor governance and compliance.
• Support audit planning, preparation and follow-up including CAPA management.
• Act as SME on vendor compliance, inspection readiness and quality practices.
• Partner with global and local stakeholders to strengthen operational consistency and regulatory compliance.
• Drive continuous improvement to vendor performance and inspection readiness.
• Deliver training and communications supporting systems adoption and compliance requirements.

Conocimientos

GCP knowledge

GxP knowledge

ICH knowledge

Regulatory inspections experience

Vendor management

Matrix leadership

Educación

University degree in business or relevant field

Descripción del empleo

Novartis in Barcelona seeks a senior vendor governance and compliance leader to drive standards across vendor operations, lead inspection readiness, and ensure regulatory compliance.

You will collaborate with global and local stakeholders, develop templates and tools, support audits, and manage corrective actions and documentation requests.

The role requires 8–10+ years in clinical operations, strong knowledge of GCP, GxP and ICH, and a proven track record in vendor management.