Quality Manager

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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

Quality 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.

As a Quality Manager at Baxter in Braine-L'Alleud, you will play a pivotal role in ensuring the compliant application of Baxter’s Quality System elements throughout our product development and risk management activities. Your expertise will support both New Product Development (NPD) and Sustaining Product Organization (SPO) projects for our Therapeutic Products and Medical Devices.

In this leadership position, you will lead all aspects of the quality management processes for new and improved marketed product designs. You will collaborate closely with cross-functional teams to ensure product quality during development and improvement phases.

What you'll do :

Quality System Implementation: Ensure that Quality System processes are successfully implemented on-site to meet the requirements for new product development and lifecycle management. This includes adherence to ICH guidelines, 21 CFR, EU GMP regulations, ISO 13485 and 14971, MDSAP, and MDD/MDR.
Regulatory Compliance: Maintain site compliance with applicable regulations and standards, ensuring that all vital certifications are upheld. Oversee compliance for pharmaceutical product storage, testing, and release in accordance with GMP certification. · Leadership in Development Activities: Provide leadership to project teams to ensure that New Product Development (NPD) and Sustaining Product Organization (SPO) activities meet established quality requirements.
Continuous Improvement: Identify Key Quality Indicators (KQIs) to provide data for continuous improvement initiatives and potential escalation of quality issues.
Audit Readiness: Maintain site audit readiness for internal, external, and unannounced audits. Drive successful audit outcomes by compiling audit responses and tracking commitments.
Internal Audit Program: Implement and actively participate as an auditor in the internal site audit program, ensuring thorough evaluations of quality processes.
NCR/CAPA Management: Lead and approve Non-Conformance Reports (NCR) and Corrective and Preventive Actions (CAPA). Drive technical support for NCR investigations, applying DMAIC tools.
Quality Core Team Participation: Function as a Quality Core Team member, supporting new and improved product design and implementation projects. Manage complex issues associated with these projects and define the scope of quality results.
Technical Feasibility Review: Review and approve the technical feasibility of sophisticated design concepts and analyze technologies from a quality perspective, collaborating across multiple fields.
Resource and Budget Management: Identify potential resource needs and funding requirements to support job responsibilities effectively.
Guidance on Documentation: Provide guidance on the creation and maintenance of Product Design History Files and Risk Management Files in accordance with relevantQuality System and regulatory requirements. Advise the R&D development group on standard methodologies in risk management and development process deliverables.

Other information:

You will work in a global environment, with international teams.
You will have to travel to different site from time to time, up to 15% per year.

What you'll bring :

Education and Experience: Degree in Pharmacy, Biological or Chemical Sciences, or Engineering with a minimum of 8 years of related experience. Strong preference for a Qualified Person.
Certifications: Preferred certifications include CQE or Six Sigma Green Belt.
Knowledge of 21 CFR 211, 21 CFR 820, ISO 13485, and ISO 14971 is highly desirable.
Communication Skills: Excellent communication, organizational, and negotiation skills, with strong oral and written abilities. Willingness to actively participate in team activities.
Analytical Skills: Strong analytical and problem-solving skills, preferably applying DMAIC tools and Six Sigma methodologies. General understanding of applied statistical methodologies.
Compliance Knowledge: Familiarity with compliance in pharmaceutical and medical device product development, including change control, CAPA, and risk management. Understanding of container requirements for pharmaceutical product registration.
Research and development focus with project management background.
Decision-Making Ability: Capable of working with minimal direction and making informed decisions with limited information.
Language Proficiency: Very good level of English; proficiency in additional languages is an asset.
Technical Skills: Basic computer skills in Word, Excel, PowerPoint, MS Project, Minitab, Outlook, and Trackwise.

What are some of the benefits of working at Baxter Healthcare Corporation?

Baxter Healthcare Corporation offers a competitive total compensation package, professional development opportunities, and a strong emphasis on work-life balance!

Join us in our mission to deliver high-quality healthcare solutions that make a difference in patients' lives!

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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 Boulevard d'Angleterre 2-4
1420 Braine-l'Alleud
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.”

Join Our Talent Community

We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Quality Manager

Overview

Success Profile

Quality Manager

What you'll do :

Other information:

What you'll bring :

Address

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Hear from Our Employees

Meet Christelle, Senior Quality Manager in Malta

Meet Lorena, Senior QA Associate in London, UK

Meet Gary, Quality Research Manager in Singapore

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Join Our Talent Community