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Sr Quality Assurance Manager

Req # JR - 155241 Location Lessines, Wallonia, Belgium Job Category Quality Date posted 02/05/2025
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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

Sr Quality Assurance Manager

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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.

The role

The Senior Quality Assurance Manager is responsible for assuring conformity of the manufacturing processes and products to the quality requirements (procedures and regulations) manufactured at Lessines site.

Essential Duties & Responsibilities

  • Supervising all activities at plant level as related to Operational Quality, Complaints and Release.

  • Assure escalation of any potential FA and gather data to assist FA process.

  • Support product release by ensuring timely review and investigation of deviations related to the manufacturing process.

  • Support NCR and CAPA process: root cause identification and continuous improvement.

  • Ensure timely documentation and closure of NCR, CAPA and complaint records.

  • Ensure timely investigation and response to ICARs.

  • Review and assess process and documentation change requests.

  • Participate in internal and external quality system audits conducted by the corporate or regulatory agency representatives.

  • Collaborate with ICO partners for projects or issue resolution (intracompany).

  • 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 area of control.

  • Perform reporting of KPI as applicable (CAPA review board, Management Review…)

  • Support 6s program.

  • Response Quality on the shopfloor during visits / audits.

  • Manage, support and develop the Operational Quality, Complaints and Release teams.

  • Monitor KPI and take action to meet target for the department

Qualifications

  • Bachelor’s degree in a relevant scientific discipline; advanced degree preferred

  • Minimum of 10 years of experience within the pharmaceutical industry, with progressively increasing levels of responsibility

  • Minimum 5 years of experience in people management

  • Fluency in French and English is a must

  • Being recognized as Qualified Person, as defined in the Directive 2001/83/EC for Medicinal products and as defined in DIRECTIVE 2001/82/EC for veterinary medicinal products is an added value

  • Problem-solving and analytical skills

  • Critical and inquisitive mind

  • Excellent communication and presentation skills

  • Resistant to stress & demonstration of flexibility in times of change

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 Rue Rene Branquart, 80
7860 Lessines
Belgium 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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