Clinical Quality Assurance & Training Lead en Madrid, España - Jobeax
Descripción de la vacante
Clinical Quality Assurance & Training Lead en Madrid, España
Crovelis
Clinical Quality Assurance & Training Lead en Madrid, España is listed on Jobeax. Browse 80,000+ vacancies available.
Clinical Quality Assurance & Training Lead – CROVELIS
Localización: Madrid
Experiencia: 5-7 años en Quality Assurance dentro de clinical research, pharma, biotech o healthcare, con experiencia en liderazgo de calidad o gestión de operaciones clínicas.
La oportunidad
En CROVELIS buscamos incorporar un/a Clinical Quality Assurance & Training Lead para liderar y desarrollar el sistema de calidad y formación de la compañía.
Será una posición clave para impulsar una cultura de calidad, asegurar el cumplimiento regulatorio y acompañar el crecimiento de la organización, garantizando que los procesos, equipos y sistemas estén preparados para afrontar los retos de una compañía innovadora de investigación clínica.
¿Cuál será tu reto?
Liderar la estrategia y mejora continua del Quality Management System (QMS) .
Garantizar el cumplimiento de estándares GxP, requisitos regulatorios y expectativas de clientes.
Definir y monitorizar KPIs de calidad, análisis de tendencias y planes de mejora.
Gestionar auditorías internas, externas y preparación ante inspecciones regulatorias.
Coordinar CAPAs, desviaciones, cambios y actividades de gestión de riesgos.
Liderar el modelo de formación y cualificación de empleados, incluyendo onboarding, SOPs y formación GxP.
Supervisar la gestión documental y los sistemas de calidad.
Colaborar con equipos internos y proveedores para asegurar la excelencia operativa.
¿Qué buscamos?
Formación universitaria en Life Sciences (Farmacia, Biotecnología, Medicina, Química u otras áreas relacionadas).
Experiencia sólida en Quality Assurance dentro de clinical research, CRO, pharma o biotech .
Experiencia liderando iniciativas de calidad, equipos o proyectos transversales.
Conocimiento profundo de GxP, ICH-GCP, auditorías, CAPAs, gestión de riesgos y compliance regulatorio .
Experiencia trabajando con sistemas como eQMS, eTMF, CTMS/TMS o DMS .
Inglés fluido (oral y escrito).
Experiencia en entornos internacionales será valorada.
Perfil ideal
Buscamos una persona con visión estratégica y capacidad para aterrizar la calidad en procesos prácticos, con habilidades de comunicación, influencia transversal y orientación a la mejora continua.
Alguien capaz de combinar conocimiento técnico, liderazgo y mentalidad de crecimiento para ayudar a construir y evolucionar el modelo de calidad de CROVELIS.
¿Por qué CROVELIS?
Formarás parte de una compañía de investigación clínica en crecimiento dentro de Insud Pharma , con un entorno innovador donde la calidad, la tecnología y la excelencia operativa son pilares fundamentales para transformar la forma en la que se desarrollan los ensayos clínicos.
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