Director Global Regulatory Compliance (Process Excellence)

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Oportunidades de carrera

Iniciativas de equilibrio laboral

Esquema de bonificación

Seguro de salud

Plan de pensiones

Job summary

Una empresa farmacéutica internacional busca un Director de Cumplimiento Regulatorio en Dublín, Irlanda. Esta persona será responsable de construir y liderar la función de cumplimiento regulatorio, supervisar la adherencia a los procesos regulatorios y desarrollar Sistemas de Gestión de Calidad (QMS). Se necesitan habilidades de liderazgo y una sólida comprensión de la industria farmacéutica. Ofrece salario competitivo, oportunidades de progreso y equilibrio entre la vida laboral y personal.

Qualifications

• Experiencia en entrega efectiva en un entorno complejo y multinacional.
• Familiaridad con auditorías en el mercado europeo.
• Habilidades interpersonales y de influencia estratégica.

Responsibilities

• Construir y liderar la función de cumplimiento regulatorio global.
• Supervisar la adherencia a procesos regulatorios y preparar auditorías.
• Desarrollar y evolucionar los Sistemas de Gestión de Calidad (QMS).

Skills

Liderazgo eficaz

Colaboración interdisciplinaria

Conocimiento de cumplimiento en la industria farmacéutica

Job description

Director Regulatory Compliance (Process Excellence) page is loaded## Director Regulatory Compliance (Process Excellence)locations: Northern Cross, Dublin, Irelandtime type: Tiempo completoposted on: Publicado hoyjob requisition id: R5665632Meda Pharma GmbH & Co KGEn 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, 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 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.#LI-DNIViatris 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.