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Manager, Quality Systems

Req # JR - 166392 Location Santiago de Cali, Departamento del Valle del Cauca, Colombia Job Category Quality Date posted 04/14/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Manager, Quality Systems

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Únete a nuestra misión de salvar y sostener vidas!

Tu rol en Baxter

Salvar y. sostener vidas. asegurando el cumplimiento de la política de calidad de Baxter de acuerdo con necesidades identificadas en el plan estratégico del negocio y lineamientos corporativos para Colombia según' las Normas ISO 9000/ISO 13485, normas de los entes regulatorios de; Colombia, Ecuador, Chile y Centro América; donde los productos de Baxter: son comercializados.

Lo que harás en Baxter

  • Cumplir con la normatividad vigente frente a temas de salud, ambiente y seguridad definidas en la CO6001A, regulaciones y normas aplicables en materia de Calidad (GMP, manuales y procedimientos de calidad), seguridad en la cadena de suministro, sistema de gestión integral de la energía y políticas corporativas relacionadas a su cargo. Así mismo, se debe garantizar el cumplimiento del Decreto 4725 de 2005 régimen de registros sanitarios, permiso de comercialización y vigilancia sanitaria de los dispositivos médicos para uso humano.

  • Asegurar la implementación de un sistema de identificación de los peligros y evaluaciónde riesgos en todas las áreas de responsabilidad del cargo.

  • Establecer prioridades de seguridad de acuerdo con el riesgo evaluado en cada área.

  • Liderar y Garantizar la implementación del sistema de calidad en Colombia de acuerdocon los lineamientos de calidad corporativos y reglamentos regulatorios locales.

  • Establecer los procedimientos de operación y de control interno necesarios para asegurar las adecuadas prácticas de control en procesos de manufactura en la planta de Colombia.

  • Liderar y garantizar el proceso de calibración de instrumentos que soportan la fabricación del producto en la planta de Cali - Colombia dando cumplimiento a las normas ISO y Corporativas establecidas.

  • Liderar y garantizar el proceso de validación de la fabricación y liberación del producto cumpliendo con las políticas Corporativas, normas regulatorias, normas internacionales (USP, ICH; etc).

  • Implementar la cultura de calidad a través de la operación y las diferentes áreas de la organización.

  • Desarrollar las personas del equipo de calidad de las áreas a cargo.

  • Ser delegado del jefe de Calidad del Sitio y director técnico de la planta y Gerente Aseguramiento de Calidad.

  • Asegurar la implementación iCare en Colombia.

Lo que aportarás Baxter

  • Profesional Universitario graduado en Química farmacéutica, Ingeniería Química o carreras afines.

  • Inglés conversacional intermedio - avanzado

  • Conocimiento en normas farmacéuticas (informe_32, Normas ISO, etc

  • Mínimo 5 años de experiencia en procesos de calidad o manufactura de productos farmacéuticos.

Postúlate!

#LI-GR1

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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Address

Explore this location Calle 36 No. 2 C 22 Barrio Santander
Cali Valle del Cauca
Colombia
Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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