03 oct
|
Novartis
|
Cataluña
Summary
This role is based in Barcelona Gran Via, Spain. Novartis is unable to offer relocation support. Please only apply if accessible.
Novartis operates a Hybrid working arrangement with an expectation of 12 days per month onsite.
About The Role Key Responsibilities
- Drive the 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 implementation of vendor risk assessment, selection, and compliance processes.
- Oversee vendor quality and compliance metrics, identifying trends, risks, and improvement opportunities.
- Develop and maintain templates, tools, and operational resources supporting vendor governance and compliance.
- Support audit planning, preparation, and follow-up, including corrective and preventive action management.
- Act as a subject-matter expert on vendor compliance, inspection readiness, and quality management practices.
- Partner with general and local stakeholders to strengthen operational consistency and regulatory compliance.
- Drive continuous improvement initiatives that enhance vendor performance, quality outcomes, and inspection readiness.
- Deliver training and communications supporting adoption of systems, processes, and compliance requirements.
Essential Requirements
- University degree in business or a 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 Good Clinical Practice and regulations (GCP, GxP and ICH).
- Demonstrated experience supporting and leading regulatory inspections and managing inspection back-room activities.
- Experience with inspection readiness, storyboards, evidence collection, and regulatory document request management.
- Experience supporting corporate or supplier audit
📌 Vendor Operations Lead (Cataluña)
🏢 Novartis
📍 Cataluña