Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe

Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe page is loaded Quality Manager (Third Party Quality) – 12/24 Month Contract – Anywhere in Europe Solicitar locations Ireland Remote Office Poland Remote Office Milan, Lombardy, Italy United Kingdom Remote Office time type Tiempo completo posted on Publicado hace 20 días job requisition id R5639031 3825 Upjohn Manufacturing Ireland Unlimited En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en evolución. Viatris permite a las personas de todo el mundo vivir de manera más saludable en cada etapa de la vida. Lo hacemos a través de: Acceso : suministro de medicamentos confiables de alta calidad independientemente de la geografía o las circunstancias; Liderazgo : promover operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente; Asociación : aprovechando nuestra experiencia colectiva para conectar a las personas con productos y servicios. Every day, we rise to the challenge to make a difference and here’s how the Quality Manager (Third Party Quality) role will make an impact: Key responsibilities for this role include: Viatris Third Party Quality is responsible for the Quality management of over 100 contract manufacturers, packagers, and supply partners globally, covering approximately 7,000 SKUs in 165 markets.The person will be responsible for contract quality assurance & regulatory change management for a number of key contractors & projects planned over the next one to two years. I nitiate, review and approve regulatory changes in the regulatory systems for changes initiated by or impacting TPQ managed Contract manufacturers. Act as liaison between regulatory and CMO for generation of filing information for projects and review the associated regulatory submission documents. Participate in Virtual Site Operating Teams (VSOT), Virtual Project Team (or similar) meetings for ES/TPQ managed Contract manufacturers & participate in Site Quality visits at the Contract manufacturers, if needed. Provide Quality Leadership for significant deviations at CMO sites that may impact compliance status or require regulatory notifications. Prepare Critical Quality Event (CQN) summaries and participate in relevant meetings. Provide Quality leadership for customer complaint investigations. Support and Perform Lot Disposition, if required, in collaboration with other functions. Lead and/or provide support to other quality projects and continuous improvement initiatives within TPQ and External Supply, as required. Perform and assist with additional duties as may be directed by Director/TL, Viatris Third Party Quality. The role is remote and can be located in Europe. The minimum qualifications for this role are: Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline. Min. 5 years of experience in GXP setting and/or Regulatory Affairs role (or 3 years with Masters degree). Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as SAP, Regulatory systems, Trackwise, Documentum platforms. Good command of English language and multi-lingual is a benefit. Strong verbal and written communication skills including presentation skills. Able to work in diverse multi-level, cross-divisional and multi-cultural working environment. Able to work remotely and deliver work independently. Take initiative and be proactive. Show strong negotiation skills and customer focus. Is diplomatic in communication with internal and external customers. Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required. En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás. About Us Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten. J-18808-Ljbffr