Manager, Compliance Quality Systems

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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, Compliance Quality Systems

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This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

Your role at Baxter:

You as Manager, Compliance Quality Systems, will be responsible for the quality assurance function at the plant level, ensuring regulatory compliance, adaptability of manufacturing processes, and operational quality. The mission of the position is to guarantee product quality and customer happiness. This is achieved by implementing management systems, controlling risks, improving continuously, and encouraging employee growth. All actions align with the business’s strategic objectives. Supervises the work of the engineers and technical personnel in charge, with the aim of guaranteeing compliance with the established specifications and ensuring the development and performance of the related quality systems.

What you will be doing:

Quality System Management

Ensure the establishment, maintenance and improvement of a quality system that meets the

with regulatory, normative and corporate requirements that allow for improvement

manufacturing processes, responding to the needs observed in the

Market complaints and behavior of the product in process.

b. Approve local specifications and procedures as a Quality Representative of the

Areas under their responsibility.

c. Act as the Quality function’s liaison during internal and external audits and interactions with regulatory bodies.

2. Risk Management and Compliance

Implement strategies to identify, assess, and mitigate quality risks in processes,

Equipment and materials.

b. To control the accurate administration of the material and human resources required for

Compliance with processes.

3. Technical and Business Leadership

Provide authority support to both on-site and off-site customers to ensure compliance with plant goals and company standards ds.

b. Promote improvement, simplification, innovation and consistency to regulatory standards projects.

c. Represent the Director of Quality in their absence and in strategic committees.

4. People Management and Talent Development

Build and complete development and training plans for the members of the department passionate about Quality.

b. Ensure the continuous training and development of the teams responsible for Quality Engineering.

c. Promotes a culture of quality, safety and continuous improvement at all levels of the organization

What will you bring?

Academic background:

Quality, Industrial, Chemical, Biomedical or related Engineering.

Experience:

10+ years in Quality roles, with at least 5 in leadership positions.
Validated experience in quality management systems in the medical, biotechnology or pharmaceutical industry.
In-depth knowledge of international laws and standards (ISO 13485, FDA, GMP, MDSAP, among others).
Technical skills:
Process engineering, validations and quality controls.
Risk analysis and problem-solving tools (FMEA, Six Sigma, CAPA).
Audit and regulatory compliance management.

Proficiency in oral and written English.

Leadership proficiencies:

2. Inspiring and focused leadership.

3. Effective communication and collaborator management.

Ability to develop high-performing teams.

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

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Address

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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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Manager, Compliance Quality Systems

Overview

Success Profile

Manager, Compliance Quality Systems

Your role at Baxter:

What you will be doing:

manufacturing processes, responding to the needs observed in the

2. Risk Management and Compliance

3. Technical and Business Leadership

4. People Management and Talent Development

Academic background:

Experience:

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