Director, Global Device Quality page is loaded## Director, Global Device Qualitylocations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5663654McDermott Laboratories LimitedEn VIATRIS, vemos la atención médica no como es, sino como debería de 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 constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**Every day, we rise to the challenge to make a difference and here’s how the **Director, Global Device Quality** role will make an impact:* Provide leadership and drive continuous improvements in quality system practices throughout the corporation to meet/exceed global regulatory requirements for device and combination products.* Align with other top-level managers in the development and establishment of corporate-wide Quality initiatives, continuous improvement programs, and key performance targets.* Function as a change leader within the Quality organization on the local and global levels to raise awareness and compliance with Viatris’ expectations and strategy for elevating quality via continuous quality improvement.* Serve as a subject matter expert regarding best practices regarding the areas involved in Quality Management Systems for device and combination products.* Evaluate, implement, and execute systems for standardizing compliant practices. Provide global oversight of standardized systems and perform "in use" verification of such global systems.* Participate in activities in support of global inspection preparedness, audit response and CAPA related to local and global systems impacting devices and combination products.* Interact with Health Authorities and Notified Bodies in a thoughtful and professional way.* Collaborate with quality colleagues and other departments to during all phases of integration activities, including the assessment of documents, processes, and systems.* Monitor regulatory trends and identify industry “best practices” for required device and combination products.* Develop training strategies and content to perform on-site and computer-based training of key personnel.* Create and review global SOPs and policies and review site SOPs to ensure alignment with global policies and procedures.**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* A Master’s degree (or equivalent) in a science related discipline is preferred with extensive experience in Research and Development, Quality and/or Regulatory Affairs.* Must possess knowledge of medical device and/or combination product regulations. Must be familiar with all concepts related to assigned quality systems.* Experience liaising directly with international health authorities including US and European authorities.* Must be articulate in both written and oral communications, including diplomatic discussion of required corrective actions with business partners. Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and current application.* Ability to present to a high level of the organization and groups outside of the organization.* People management experience would be preferred.At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn 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.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.
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