Pharmacovigilance Quality Manager

hace 4 semanas


Ciudad de México IQVIA A tiempo completo

Job Overview
This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines.

This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions.

Essential Functions
- Adopt and implement the global Quality Management Plan within the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
- Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
- Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
- Provide advice and support to teams within the assigned business line and other key stakeholders on all aspects of Good Clinical Practice (GCP) compliance.
- Work in close cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);
Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;
- Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
- May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
- Act as the primary contact for Quality Assurance on quality matters - on the level of the assignment, attend meetings/teleconferences.
- Prepare periodic reports to business lines on quality related matters, risk assessments and specific quality improvement initiatives.

**Qualifications**:

- Bachelor's Degree in health science
- Minimum 3 years of working experience in Pharmacovigilance/ Safety area.
- Advanced English level
- Knowledge of National and International Regulations and Drug Development processes.
- Knowledge of Clinical Research Organization (CRO) or Pharmaceutical industry operations.
- Good organizational, interpersonal and communication skills.



  • Ciudad de México Galderma Pharma S.A A tiempo completo

    Pharmacovigilance Coordinator page is loaded Pharmacovigilance Coordinator Apply locations São Paulo Mexico City time type Full time posted on Posted 2 Days Ago job requisition id JR009637 With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90...

  • Quality Manager

    hace 1 mes


    México Lear Corporation A tiempo completo

    Location: Torreon, COA, MX**Quality Manager**: **Quality Manager** **Job based in Torreon, Matamoros, Coah. Torreon I Plant, E-Systems division** Lear Corporation is the leading Tier 1 automotive supplier serving all the world's major automotive manufacturers with our world-class automotive seating and automotive electrical products. Our products are...

  • Quality Manager

    hace 1 mes


    Ciudad Juarez, México Lear Corporation A tiempo completo

    Location: Juarez, MX**Quality Manager**: **Job Title**: Quality Manager - Improve the customer satisfaction accomplishing their requirements_ **Lear Corporation - Ciudad Juarez, Chihuahua, Mexico Torres Plant (Presential)** **Drive Your Career** Lear Corporation is the leading Tier 1 automotive supplier serving all of the world's major automotive...

  • Quality Manager

    hace 1 mes


    Ciudad Juarez, México Lear Corporation A tiempo completo

    **Job Title**: Quality Manager - Improve the customer satisfaction accomplishing their requirements_ **Lear Corporation - Ciudad Juarez, Chihuahua, Mexico Torres Plant (Presential)** **Drive Your Career** Lear Corporation is the leading Tier 1 automotive supplier serving all of the world's major automotive manufacturers with our world-class automotive...


  • Ciudad de México Thermo Fisher Scientific A tiempo completo

    Provides administrative safety support to the safety reporting team and Pharmacovigilance department. Responsible for tasks related to receipt and submission of expedited and periodic safety reports, including quality check tasks, pertaining to the department’s projects. Assists management in producing project metrics as required. Involved in projects and...

  • Quality Manager

    hace 4 semanas


    Ciudad Juarez, México COFICAB A tiempo completo

    **COFICAB** **Solicita**: **Quality Manager** **Descripción y Requisitos** **Position objective**: Plans, oversees and coordinates all Quality activities and operations, such as Quality Department budgeting and planning, Quality System Management, process and product control including non-conformity treatment, customer claim Management, Metrology and...

  • Quality Manager

    hace 3 semanas


    Ciudad de México City of Shakopee, MN A tiempo completo

    RESPONSABILITIES: Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product. Assure product safety and reliably meets company standard. Formulate and maintain quality control objectives and coordinate objectives with production procedures in...

  • Quality Manager

    hace 1 mes


    Ciudad Juarez, México HAT Talent Search A tiempo completo

    **Quality Manager** **Experience in Electronic devices - SMT/PCB Process.** For business growth, Manufacturing plant located in Ciudad Juarez is searching for **Quality Manager. **The incumbent will be responsible of overall management of Quality site activities related to customer quality, manufacturing process quality and supplier quality driving...

  • Quality Manager

    hace 1 mes


    Ciudad Juarez, México Arias A&A Talento Humano Consultores A tiempo completo

    1. BA Degree 2. Familiar with all the QA tools and related knowledge is must. 3. +5 years of experience in management position 4. Experience in the electronic industry 5. Bilingual Tipo de puesto: Tiempo completo Salario: $90,000.00 - $120,000.00 al mes Horario: - Turno de 8 horas Educación: - Licenciatura terminada (Obligatorio) Experiência: -...

  • Quality Manager

    hace 1 mes


    México Johnson Electric A tiempo completo

    Quality manager - Come Join Innovate Motion with Us_ Your responsibilities will be: - Develop standardized production, quality, and customer-service standards - Identify potential risks before they become a problem, focusing on root cause analysis and preventive action - Perform internal and external quality audits and compile detailed reports of...

  • Quality Manager

    hace 1 mes


    Villa de Reyes, México Metal Technologies Inc. A tiempo completo

    Descripción del trabajo y responsabilidades: **Position: Quality Manager Reports to: Plant Manager**: **Supervise: Quality Department** 1.0 General Summary: - Participates in the Quality System Management to ensure customer satisfaction by improving quantitative processes. - Work closely with all departments to ensure continuous improvement, in accordance...


  • Ciudad de México BD A tiempo completo

    **Job Description Summary**: How about belonging a leading global medical technology company that acts advancing the world of health? Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over...


  • México Faurecia A tiempo completo

    New trends and expectations are reshaping the automotive industry. Inspired by the exciting new challenges associated with this revolution, **Faurecia (Forvia's group) **anticipates the future of mobility developing cutting-edge solutions for smart life on board and sustainable mobility. If you’re willing to contribute and create value for tomorrow’s...

  • Quality Manager

    hace 1 mes


    Ciudad de México Upfield A tiempo completo

    **Quality Manager** **Ciudad de México** **¡Nuestro equipo de Supply Chain está en búsqueda de talento!** Como Gerente de Calidad serás responsable de lograr la satisfacción de nuestros clientes y consumidores a través del cumplimiento de los estándares de calidad corporativos y los requerimiento legales vigentes - Dentro de las principales...

  • Quality Team Manager

    hace 2 semanas


    Ciudad de México City of Shakopee, MN A tiempo completo

    Quality Team Manager  Responsabilidades:  Diseñar procedimientos, estándares y especificaciones de calidad, implementarlos y garantizar su buen funcionamiento. Estudiar los requisitos del cliente para garantizar que se cumplan. Trabajar con otros departamentos, como marketing o ventas, para establecer los requisitos de calidad de los clientes y de los...

  • Quality Manager

    hace 1 mes


    Ciudad Juarez, México Werner Co A tiempo completo

    **Quienes somos**: WHY WERNER? BECAUSE WE ARE THE PRO'S CHOICE! You will find our market leading products and brands on trucks and job sites all over the world. Focusing on end users' needs drives our success. Our entire product development process—from research to engineering to manufacturing to commercialization—creates products that ensure ease of...


  • Ciudad de México Citi A tiempo completo

    The ** IT Quality Program Group Manager** is accountable for management of complex/critical/large professional disciplinary areas. Leads and directs a team of professionals. Requires a comprehensive understanding of multiple areas within a function and how they interact in order to achieve the objectives of the function. Applies in-depth understanding of...

  • Quality Engineer

    hace 12 horas


    Ciudad de México General Motors A tiempo completo

    This is an onsite job: What you will do: Support GPS Quality Requirements. Monitor consistency to Global Metric Performance. Actively participate in Plant Quality Meetings. Manage RED X / OpEx projects as requested from Quality Manager. Proficiency and knowledge of the elements of the GM Quality System / GMS BIQ and of the Quality Launch Plan. ...


  • Ciudad de México Bosch Group A tiempo completo

    Company Description Do you want beneficial technologies being shaped by your ideas? Whether in the areas of mobility solutions, consumer goods, industrial technology or energy and building technology - with us, you will have the chance to improve quality of life all across the globe. Welcome to Bosch. Work #LikeA**Bosch** **Job Description**: Work...

  • Quality Manager

    hace 4 semanas


    México Hitachi Automotive Systems Americas, Inc. A tiempo completo

    Basic Function : Develop, maintain, and manage a Quality Assurance (QA) Organization that is effective at ensuring compliance to all regulatory, customer and mandated requirements. Set goals, objectives, and daily directives for direct reports. Develop quality assurance staff by planning, monitoring, and appraising job results accompanied by coaching and...