Director, Global Device Quality page is loaded## Director, Global Device Qualitylocations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R5663654McDermott Laboratories LimitedChez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:*Accès*: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.*Leadership*: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.*Partenariat*: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.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 visitChez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.
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