Descripción de la vacante
W Executive España
Spain, Vitoria
Contract Production Manager en Vitoria, España is listed on Jobeax. Browse 80,000+ vacancies available.
Contract Manufacturing Manager (CMO) Reporta a: Chief Executive Officer (CEO) Departamento/Área: Operaciones / Contract Manufacturing Organization (CMO) Gestionar la relación estratégica y operativa con fabricantes externos (CMO/CDMO), garantizando la correcta transferencia de tecnología, industrialización y fabricación de productos conforme a los estándares de calidad, normativa GMP, plazos de suministro y objetivos económicos de la compañía. Será responsable de coordinar las actividades técnicas y operativas con los fabricantes externos, asegurando la continuidad del suministro, la mejora continua de los procesos y el cumplimiento de los requisitos regulatorios y contractuales durante todo el ciclo de vida del producto. Gestión de fabricantes externos (CMO/CDMO) Identificar, evaluar y homologar nuevos fabricantes externos para productos farmacéuticos. Desarrollar y mantener una red estratégica de fabricantes que garantice capacidad, competitividad y continuidad del suministro. Establecer relaciones sólidas y acuerdos de colaboración con los socios industriales. Evaluar las capacidades técnicas, operativas y de producción de nuevos fabricantes. Liderar los proyectos de transferencia de tecnología desde I+D hasta fabricación comercial. Coordinar la implantación industrial de nuevos productos con los fabricantes externos. Liderar las actividades de validación de procesos de fabricación y acondicionamiento. Participar en la revisión y aprobación de documentación técnica y de calidad, incluyendo: Change Controls Product Quality Reviews (PQR/APR) Gestión operativa Supervisar el cumplimiento del plan mensual de fabricación con los fabricantes externos. Asegurar el cumplimiento de los plazos de producción y suministro. Dar soporte técnico en la resolución de incidencias de fabricación y desviaciones. Elaborar planes de mejora para incrementar la eficiencia operativa y la calidad. Impulsar proyectos de optimización de procesos orientados a reducción de costes, mejora de productividad y aumento de capacidad. Compartir las mejores prácticas entre los diferentes fabricantes. Gestión contractual y cumplimiento Garantizar el cumplimiento de los compromisos técnicos y operativos establecidos en los contratos con los fabricantes externos. Velar por el cumplimiento de los requisitos establecidos por las autoridades sanitarias y organismos reguladores nacionales e internacionales. Dirección General Calidad (QA/QC) Producción Planificación Contract Manufacturing Organizations (CMO) Contract Development & Manufacturing Organizations (CDMO) Laboratorios externos Formación requerida (H/M/D) Grado o Licenciatura en Farmacia. Ingeniería Industrial o similar. Administración y Dirección de Empresas (ADE), Economía o similares, siempre que se complemente con experiencia técnica en la industria farmacéutica. Experiencia Mínimo 5 años gestionando fabricantes externos (CMO/CDMO). Al menos 6 años de experiencia en la industria farmacéutica o sectores regulados. Experiencia demostrable en: Transferencia tecnológica, Validación de procesos., Fabricación farmacéutica, Desarrollo e industrialización de nuevos productos, Formulación, fabricación, llenado y acondicionamiento de medicamentos, Experiencia en gestion de proyectos multidisciplinares, Experiencia trabajando bajo normativa GMP. Idiomas Español: Nativo o bilingüe. Inglés: Nivel alto (C1) tanto oral como escrito. Gestión de proyectos. Gestión de riesgos. Orientación a la calidad. Visión estratégica de operaciones. Planificación y organización. Trabajo en equipo. Orientación al cliente interno y externo.
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