Director Regulatory Compliance (Process Excellence) page is loaded## Director Regulatory Compliance (Process Excellence)locations: Northern Cross, Dublin, Irelandtime type: Temps pleinposted on: Offre publiée aujourd'huijob requisition id: R*******Meda Pharma GmbH & Co KGChez 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, Regulatory Compliance**role will make an impact.
**Key responsibilities for this role include**:The **Director, Regulatory Compliance** will build and lead a newly established Global Regulatory Affairs (GRA) Compliance function, with responsibility for defining, embedding and continuously improving compliance across GRA.
The role will partner closely with cross-functional stakeholders to monitor adherence to regulatory processes, lead audit and inspection readiness and learning, and own the development and evolution of the GRA Quality Management System (QMS).
**Compliance*** Leadership and oversight on GRA compliance related topics, inspection & audit outcomes and trending.
* Provision and as needed escalation of GRA compliance related topics to Senior Leaders* Oversight of authorities' inspections and internal audits of GRA, incl.
outcome & findings monitoring; tracking and monitoring of QE/CAPA related activities for GRA* Strong support in compiling and collecting information being presented to auditors* Close connection to and collaboration with cross-functional teams related to compliance in and outside GRA**Quality Management System (QMS)*** Develop and Evolve the GRA Quality Management Systems (QMS), incl.
GRA process hierarchy, procedure design, review and approval process, regular risk assessments, maintenance of a GRA Quality Plan, oversight on Management review of systems and a high-level definition of GRA roles and responsibilities**Regulatory Process Adherence Oversight*** Oversight of GRA controlled Documents, review and sometimes approval of new GRA procedures* Monitoring process adherence in GRA incl.
cross-functional involvement and strategic partnership on all aspects related to regulatory process adherence oversight* Oversight on procedures owned outside GRA but where regulatory is listed in the responsibility section and/or being trained on.
* Close collaboration with the extended leadership team on all compliance and process adherence related topics, review and input into curricula and support for evaluation of training needs throughout GRA.
**About Your Skills & Experience*** Engaged leader with demonstrable experience of effective delivery in a complex matrix and multi-national environment and experienced in audit and inspection conduct in a European Market* Knowledgeable and engaged in all matters related to compliance in the pharmaceutical industry* Collaborative team player with excellent interpersonal and strategic influencing and cross-functional working skills.
* Proven ability to partner successfully with other Regulatory functions, Quality, Safety, Medical and other internal stakeholders to achieve objectives.
**Benefits at Viatris**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.
Some of our benefits include the following on top of a competitive salary:* Excellent career progression opportunities* Work-life balance initiatives* Bonus scheme* Health insurance* Pension**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.
#LI-DNIViatris est une entreprise mondiale de services de santé créée en **** 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 ****** 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.
#J-*****-Ljbffr