Technical Director/ Quality Assurance Sr. Mgr

hace 1 mes

Buenos Aires, Argentina Bristol-Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb es un empleador que brinda igualdad de oportunidades. Las personas que apliquen para cualquier vacante, y que estén calificadas para la misma recibirán consideración para el empleo sin distinción de raza, color, religión, sexo, orientación sexual, identidad de género, nacionalidad, edad, discapacidad, condición de veterano protegido, embarazo, ciudadanía, estado civil, expresión de género, información genética, afiliación política o cualquier otra característica protegida por la ley.

**Location**:
Buenos Aires - Luis Guillón, Ezeiza

Laboratio de BMS- dentro land lord Roemmers

R esponsabilidades

Garantizar un Sistema de Calidad alineado a los requerimientos de Directivas/ Políticas de la Compañía y cumplimiento con Regulaciones de la Autoridad Sanitaria.

Establecer estrategias para garantizar que las actividades de la unidad de Q&C acompañen a que los lanzamientos sean realizados en tiempo y forma

Garantizar la continuidad del negocio liberando el producto terminado en tiempo y forma para asegurar su disponibilidad al paciente.

Establecer comunicaciones efectivas con la Autoridad Sanitaria para garantizar que, ante situaciones particulares que se puedan presentar, se tomen acciones alineadas tanto con las necesidades de nuestros stakeholders como con las políticas BMS y regulaciones locales.

Manejar situaciones difíciles con la Autoridad Sanitaria por ejemplo ante una falta o un recupero del mercado, etc realizando actividades y comunicaciones dentro de un adecuado balance entre los Riesgos, las regulaciones locales y las políticas BMS.

Fortalecer el pensamiento de calidad dentro de toda la organización BMS a través de la divulgación de la Promesa de Calidad.

Participar de las reuniones del Comité Operativo de la Compañía (Leadershipteam).

Establecer estrategias para el desarrollo del equipo, identificar talentos y apoyar a los equipos.

Garantizar que no se genere desabastecimiento de producto en el mercado relacionado con eventos de calidad.

Como Director Técnico, actuar como la Persona Calificada(QP) que garantice la farmacovigilancia, los procesos logísticos, las presentaciones regulatorias, las transferencias de tecnología adecuadas y los análisis locales.

Realizar el dictámen de los productos

Autorizar Procedimientos Operativos Standard, Métodos de análisis, Protocolos y Reportes de Validación, Controles de Cambios, etc.

Asegurar la emisión y cumplimiento del Manual de Calidad

Garantizar la gestión de las investigaciones de desvíos y manejo de CAPAs.

Garantizar la existencia de un Sistema de Manejo de Riesgos.

Garantizar la gestión del manejo de Controles de Cambio

Asegurar la atención a los reclamos de calidad y la conducción de las investigaciones correspondientes.

Garantizar el cumplimiento con el Programa Anual de Estabilidad de mercado conforme requerimientos regulatorios.

Asegurar la implementación de los Programas de Auditorías Internas y Auditorías Externas.

Autorizar los Contratos de Calidad Inter compañía y con Servicios Externos, conforme lineamientos de Casa Matriz.

Brindar a los distintos sectores el soporte técnico necesario para la resolución de eventuales problemas.

Asegurar la existencia y el cumplimiento de un Programa de Capacitación Anual conforme las necesidades.

Establecer objetivos operacionales y delegar funciones a los reportes correspondientes.

Asegurar el monitoreo de Métricas de Q&C Argentina.

Asegurar la consolidación y emisión del Reporte de Eventos Significativos para Casa Matriz.

Garantizar y cumplir los objetivos financieros del área.

Liderar el Quality Council local.

Asegurar el cumplimiento de los procesos de NTM y Recall/Simulacro de Recall, cuando aplique.

Reportes (A quien reporta / Quien le reporta)

Reporta a: Director, In-Markets Quality, Latin America

Reportes: Quality Assurance Manager Argentina - Co-Technical
Director/s - Quality Assurance Coordinators

Competencias
- Título de grado Farmacéutico Nacional con habilitación de matrícula y bloqueo de título provincial
- Dominio de idioma inglés / Manejo de Microsoft Office
- Capacidad para aplicar los comportamientos BMS Biopharma requeridos.
- Capacidad en la toma decisiones que dan soporte a la Estrategia y la Misión de la organización.
- Capacidad de organización, nívelar el trabajo y adminis

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