09 oct
|
Novartis
|
Madrid
SummaryThis 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 RoleKey ResponsibilitiesDrive 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 RequirementsUniversity 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 audits and developing and managing corrective and preventiv
📌 Vendor Operations Lead (Madrid)
🏢 Novartis
📍 Madrid