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cmc-d team lead

hace 1 mes

Barcelona, Barcelona, España Morgan Philips Executive Search A tiempo completo

Mi cliente es una reconocida multinacional farmacéutica con un fuerte enfoque en la innovación y el desarrollo de productos de alta calidad.

Estamos buscando incorporar un CMC-D (Consumer Health) Team Lead para apoyar el desarrollo de la estrategia de CMCD (Módulo 3 y QoS) de la línea de productos nuevos y existentes de Consumer Health de la compañía.

Las funciones principales:

  • Líder de Marca para Productos de Consumer Health.
  • Gestionar la estrategia CMCD para marcas asignadas en proyectos de NPD y LCM.
  • Redactar documentos científicos complejos (TRDs), informes y respuestas a preguntas de las autoridades sanitarias; aprobar TRDs para NPDs.
  • Realizar evaluaciones CMC-D para proyectos de diligencia debida.
  • Gestionar evaluaciones de impacto de cambios CMC-D.
  • Liderar iniciativas de mejora continua en la categoría.
  • Proporcionar entrenamiento y mentoría a su equipo.
  • Gestionar procesos funcionales relevantes.

Cualificaciones:

  • Licenciatura en un campo científico relevante (por ejemplo, Química, Bioquímica, Biotecnología) o equivalente internacional, con más de 6 años de experiencia práctica en un rol técnico dentro de la industria farmacéutica o relacionada.
  • Maestría o superior en un campo científico relevante, con más de 4 años de experiencia comprobada.
  • Doctorado en un campo científico relevante, con experiencia práctica preferida.
  • Sólido entendimiento de los procesos de desarrollo de productos.
  • Conocimiento de ICH y otros sistemas de calidad.
  • Familiaridad con regulaciones, requisitos regulatorios y estándares de la industria.
  • Fuerte comprensión de cGMP, principios de Garantía de Calidad y equivalentes.
  • Habilidades analíticas y de resolución de problemas, con capacidad para priorizar y gestionar múltiples proyectos simultáneamente.
  • Buenas habilidades de comunicación e interpersonales, con capacidad para colaborar efectivamente con equipos multifuncionales.
  • Dominio del inglés, tanto escrito como verbal. Otros idiomas son una ventaja.
  • Detallista con capacidad para mantener documentación y registros precisos.
  • Capacidad para trabajar de manera independiente y en equipo en un entorno global y dinámico.

Ofrecemos:

  • Un entorno de trabajo dinámico y colaborativo.
  • Oportunidades de desarrollo profesional y crecimiento.
  • Un paquete competitivo de beneficios.

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