Regional Clinical QA Head Latam

hace 4 semanas

Ciudad de México Novartis A tiempo completo

2023 will see Sandoz become a standalone organization As a global market leader in Generics and Biosimilar medicine, Sandoz is stepping forward from a position of strength Those joining Sandoz in the coming months will help shape the future of the company, its growth, innovation, culture and how Sandoz impacts the lives of millions. These will be careers with genuine impactThis is one such role
Are you ready to make a difference?
- Manage all operational aspects of assigned clinical trials / projects -Accountable for quality & completeness of qualification & governance documentation
- Provide mentorship/coaching -Identify training needs & prepare/develop adequate training materials
- Ensures trial site selection, activation, enrolment, resource allocation, timelines & budget commitments are delivered per established trial objectives
- Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt & Distribution of marketing samples (where applicable) Risk-based and proactive execution of local/ regional activities of Clinical Quality Assurance oversight in Country Organizations/legal entities in LatAM in close collaboration with global Development QA organization, ensuring clinical compliance and inspection readiness of regional/local.
- Clinical Operations and Medical Affairs, a fit for purpose Clinical Quality Management System (QMS) in line with corporate QMS, and collecting/reporting KPIs and KQIs to relevant Quality Council.
- Build and maintain regional/local CQA network and organisation -Develop and implement regional/local CQA network in collaboration with regional/local clinical operations entities (pre-/clinical, BD&L, Medical Affairs)
- Contributes to generic parts of Sandoz QMS, ensure and support appropriate implementation locally
- Ensures establishment and implementation of procedures in line with global QMS and local regulatory requirements, in collaboration with regional/local clinical operations entities (pre-/clinical) and Sandoz Country Quality
- Acts as link between global CQA organization and all other appropriate stakeholders within Sandoz organisation (e.g. Auditing & Compliance, Pharmacovigilance / Drug Safety, Clinical Development, Medical Affairs, Heads of Country Organisations, Pre-Clinical etc.)
- Ensures compliance with Sandoz global and local country clinical/GCP regulations -Ensures the creation and execution of clinical part of Site Quality Plan in alignment with SGD Quality plan

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Graduate in Pharmacy, Life Sciences or Medical Science
- English and Spanish fluent in speaking and writing
- At least 5 years experience in Clinical Operations or Clinical Quality Management Good knowledge of global regulatory framework, GCP experience, knowledge of EU and FDA regulations, ICH requirements and common quality standards
- Experience in an international matrix organisation desirable
- Good intercultural communication and negotiation skills
- Strong analytical and organisational skills Entrepreneurial, dedicated, inspiring, process and performance oriented personality with innovative and critical thinking

ORBIT

What you’ll bring to the role:
You’ll receive: (not mandatory)Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.

Why Sandoz?500 million patients were touched by Sandoz generic and biosimilar medicines in 2021and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiouslytackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never tryingImagine what you could achievehere at Sandoz

**Division**

SANDOZ

**Business Unit**

Quality STO

**Country**

Mexico

**Work Location**

Ciudad de México

**Company/Legal Entity**

SDZ MEX

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

  • Director, Clinical Development Oncology

    hace 3 semanas

    Ciudad de México Gilead Sciences, Inc. A tiempo completo

    Director, Clinical Development Oncology – LATAM region page is loaded Director, Clinical Development Oncology – LATAM region Bewerben locations Mexico - Mexico City posted on Vor 9 Tagen ausgeschrieben job requisition id R0040649 For Current Gilead Employees and Contractors: Please log onto your Internal Career Site to apply for this job. At...

  • Intellectual Property Counsel Latam

    hace 2 días

    Ciudad de México, Ciudad de México Holcim LatAm A tiempo completo

    ¿QUIÉN ES HOLCIM?Somos el líder mundial en soluciones innovadoras y sostenibles para la construcción mediante cuatro segmentos de negocio: cemento, concreto/hormigón pre mezclado, agregados, soluciones y productos. Nuestro objetivo es impulsar la construcción circular para construir más con menos. Gracias a nuestro enfoque en la reducción de...

  • Regional Mid Market Head LATAM

    hace 1 semana

    Ciudad de México CHUBB A tiempo completo

    KEY OBJECTIVE: Dirigir la estrategia del segmento de medio mercado para Chubb LATAM en la línea de negocio Property & Casualty (P&C) en coordinación con las áreas técnicas regionales y locales de suscripción para Daños, Responsabilidad Civil, Propiedad, Marine y Líneas Financieras. Diseñar y ejecutar la estrategia de negocio para Middle Market,...

  • QA Automation

    hace 1 mes

    México Quid A tiempo completo

    Senior QA Automatización (Remoto - Latam) Buscamos Senior QA Automation preparado para nuevos y emocionantes desafíos. Este profesional debe ser bueno para agilizar y mejorar la eficiencia del proceso de prueba de software, lo que lleva a una identificación más rápida y confiable de defectos y problemas en el producto. Requisitos...

  • Clinical Research Medical Advisor

    hace 1 mes

    Ciudad de México Novartis A tiempo completo

    392648BR **Clinical Research Medical Advisor**: Mexico **About the role** **Work Model**:Hybrid **Locality**:Mexico **About the Role**: - To provide clinical strategic and tactical leadership in the country/cluster to support Development and NIBR trials, clinical development plans which change the world, concept sheets/protocols and other clinical...

  • Head of Responsible Investment Spanish Latam

    hace 8 horas

    Ciudad de México Principles for Responsible Investment A tiempo completo

    **LOCATION**: Mexico City - **BASIS**: Full-time - Permanent - **SALARY: €** 828,000 - 970,000 MXN (Mexican Peso) - **CLOSING DATE**: 8:00pm, 9th Jul 2023 -05 The Head of Responsible Investment for LATAM RI Ecosystems will have the overall responsibility for enhancing Responsible Investment awareness and practises across the Latin American region...

  • Regional Vice President

    hace 1 mes

    Ciudad de México Zscaler A tiempo completo

    The ideal candidate will own responsibilities for building and leading a team of Regional Sales Directors and Regional Sales Managers to achieve revenue goals as well as help enable MQL efficiencies, upward mobility opportunities, and channel velocity. This leader will help shape and deliver on a strategy to build mindshare on Zscaler’s products and...

  • Regional Head of Payroll

    hace 1 mes

    México Webhelp A tiempo completo

    **Location** - Obregón, Mexico**Language** - Spanish*** **¡We are hiring Regional Head of Payroll!** For Webhelp Obregón company Ensure the quality of the regional payroll services granting the correct payment of the game changers. Analysis of the department information to take strategic decisions. Update the documentation and the internal process of...

  • Team Lead, Tmf Operations

    hace 1 mes

    Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **7036** **Employment Type***: **Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our...

  • Regional Applications Specialist

    hace 2 semanas

    México Erba Technologies Austria A tiempo completo

    Regional Applications Specialist - LATAM Mexico, MX - %LABEL_POSITION_TYPE_REMOTE% Regional Applications Specialist - LATAM The Application Specialist role is to be responsible for conducting technical trainings for distributors/sales and use trainings to end-users after installation of instruments, as well as solving application/product problems; to...

  • CEVA Clinical Reviewer

    hace 1 semana

    Ciudad de México IQVIA LLC A tiempo completo

    Job Overview In-depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International. Provide departmental support to Clinical Event Validation and Adjudication (CEVA) Management and project support to CEVA Project Managers/Leads. Support provided is typically broad in scope...

  • CEVA Clinical Reviewer

    hace 1 semana

    Ciudad de México IQVIA Argentina A tiempo completo

    Job Overview In-depth knowledge of applicable global, regional and local clinical research regulatory requirement; i.e. Good Clinical Practice (GCP) and International. Provide departmental support to Clinical Event Validation and Adjudication (CEVA) Management and project support to CEVA Project Managers/Leads. Support provided is typically broad in scope...

  • Regional Clinical Research Associate Level II

    hace 4 semanas

    México ESTERN Medical LLC A tiempo completo

    Regional Clinical Research Associate Level II & III Mexico Business Title Regional Clinical Research Associate Level II & III Requisition ID EM-R-CRA-1003 Job Category Regional Clinical Research Locations Job Description Job Summary: Assures the implementation of project plans as assigned. Site administration and site monitoring responsibility for...

  • QA Automatización Uft Presencial

    hace 1 mes

    Ciudad de México Testing IT A tiempo completo

    Somos Partner ISTQB, tenemos más de 15 años de experiência en fábrica de software, desarrollo e integración para México, Latam y EEUU, con mucha capacitación, certificaciones y muy buen ambiente de trabajo, buscamos para nuestro equipo un ingeniero de pruebas automatizadas con UFT en esquema presencial. - Ingreso de $35,000 a $45,000 pesos libres...

  • Head hunter

    hace 1 mes

    Ciudad de México Manpower S.A. de C.V A tiempo completo

    Importante empresa multinacional con más de 100años en el mercado busca  Funciones: - Reclutamiento de perfiles Administrativos y especializados (LATAM)- Head Hunting de perfiles especializados. - Entrevistas por competencias. - Evaluación de candidatos a nivel global. - Diseñar y ejecutar estrategias efectivas de reclutamiento para atraer talento. -...

  • QA Pruebas Middle Cdmx Híbrido

    hace 1 mes

    Ciudad de México Training Talent A tiempo completo

    Partner ISTQB con más de 15 años de experiência en fábrica de software, desarrollo e integración para Mexico, Latam y EEUU, con mucha capacitación, certificaciones y muy buen ambiente de trabajo, buscamos para nuestro equipo un ingeniero de pruebas manuales Middle en esquema híbrido (2días en oficina): - Ingreso de $20,000 a $25,000 pesos libres...

  • Gerente de Operaciones Clinicas

    hace 1 mes

    Ciudad de México Boehringer Ingelheim A tiempo completo

    **Gerente de Operaciones Clinicas** **-** **234439** **NUESTRA EMPRESA** En Boehringer Ingelheim desarrollamos terapias innovadoras para mejorar la salud de las personas y los animales. Como empresa familiar fundada en 1885, Boehringer Ingelheim tiene una perspectiva a largo plazo. Hoy somos 52.000 personas trabajando en todo el mundo, fomentando una...

  • Country Clinical Quality Manager

    hace 4 semanas

    Ciudad de México MSD A tiempo completo

    **Job Description**: It is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives. Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the...

  • Assoc Clinical Specialist/ Cdmx

    hace 4 semanas

    Ciudad de México Medtronic A tiempo completo

    **Careers that Change Lives** **A Day in the Life** Responsibilities may include the following and other duties may be assigned. - Conducts on-site education and / or consulting. - Supports field personnel in providing the best possible outcomes and service for Medtronic customers. - Partners with sales colleagues to develop and execute plans of sales for...

  • Sr Clinical Specialist

    hace 4 semanas

    Ciudad de México Medtronic A tiempo completo

    **Careers that Change Lives **A Day in the Life Responsibilities may include the following and other duties may be assigned. - Conducts on-site education and / or consulting. - Supports field personnel in providing the best possible outcomes and service for Medtronic customers. - Partners with sales colleagues to develop and execute plans of sales for within...