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QA Operations Manager

Req #: JR - 032034 Location Lessines, Wallonia, Belgium Job Category: Quality Control Date Posted: 01/09/2021

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 Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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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

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QA Operations Manager

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.

Summary

  • Assure conformity of the manufacturing processes to the quality requirements (procedures and regulations).
  • Assure CAPA process is applied in compliance to applicable procedure and regulations).
  • Assure the conformity of the Complaint Process in relation to Intra-Company product (procedures and regulations).

Essential Duties and Responsibilities

  • Assure cGMP and other requirements are followed in the area of responsibility (Sterile Drugs & Plastics).
  • Manage all process quality related activities.
  • Assure escalation of any potential FCA and gather data to assist FCA process.
  • Support product release by ensuring timely review and investigation of Event and Non-conformities related to manufacturing process.
  • Support CAPA process: Root cause identification and continuous improvement.
  • Ensure timely documentation and closure of non-conformance and CAPA records.
  • Ensure timely investigation and response to ICAR.
  • Review and assess process and documentation change requests.
  • Participate in internal audits and external quality system audits conducted by the Corporate or regulatory agency representatives.
  • Support quality systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives.
  • Ensure training is completed for its area of control.
  • Perform reporting of KPI as applicable (CAPA review Boad, Management Review…).
  • Support 6S program.
  • Be the quality on the floor (Oversight, Investigation, inspection, Tier meeting…).

Qualifications

  • Minimum bachelor’s degree of science, bachelor’s degree of engineering or equivalent acquired through relevant experience.
  • 5-10 years of experience in Quality or Manufacturing experience in a GMP regulated environment
  • Fluent in English and French
  • Dedication to Quality. Knowledge of GMP, Root cause investigation and technical writing and basic statistics.
  • Good and effective communication skills
  • Experience in people management: interact efficiently with team members and all the different stakeholders.
  • Team spirit minded.
  • Dynamic and motivated.
  • Is very well organized, has an analytical and critical mind, is results oriented.
  • Ability to work in a changing environment.
  • Accountable and integer

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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."

Christelle

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."

Lorena

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."

Gary

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.

Christelle

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."

Lorena

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."

Gary

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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