Quality 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.

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.

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