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Senior Quality Systems Manager

2 months ago


Deerfield Beach, Florida, United States Baxter Healthcare Corporation Full time
About Baxter Healthcare Corporation

This is where you contribute to saving and sustaining lives.

At Baxter, our mission connects us deeply. Regardless of your position, your contributions positively impact individuals globally.

Throughout the organization, you will experience a sense of purpose, knowing that your efforts enhance outcomes for millions of patients.

Baxter's innovative products and therapies are utilized in nearly every hospital around the globe, in clinics, and at home. With over 85 years of pioneering medical advancements, we continue to transform healthcare.

Your Role at Baxter
This is where your innovative thinking tackles challenges.

You are resourceful, meticulous, and a dedicated executor. You embrace challenges and leverage your team's collaborative strengths to achieve outstanding results. You thrive in a dynamic environment where no two days are alike.

As a Senior Quality Systems Manager, you navigate essential internal processes to support a product you are passionate about.

You are adept at interpreting complex procedures and data, and you can train your colleagues as necessary. You take pride in delivering results promptly without compromising safety or quality.


This position is accountable for developing policies and procedures that foster continuous improvement and regulatory compliance within Baxter's global Quality Management System, specifically focusing on Chapter - Development & Design Lifecycle Management.

Chapter 2 encompasses design and development, risk management, label development, change control, and regulatory approvals.

Your Team at Baxter
In the Quality department, every role is crucial. Baxter's products are distributed worldwide to patients in need.

Whether creating a new process from the ground up or overcoming unprecedented production challenges, Quality team members are empowered to bring their creativity to the forefront.

Regardless of your specific responsibilities, your work will contribute to our global operations.

The mission of Baxter is to save and sustain lives, a principle that is integral to all our actions.

This means that when faced with a decision between quantity and quality, we will always prioritize quality.

Our patients are our top priority, always.

The Quality function values collaboration and independent work. We thrive in environments that encourage teamwork and open communication. As the company evolves, so does our approach to creating high-quality products.

We build strong relationships to accomplish our goals. These connections are fostered by our shared values of reliability, ethics, and compassion. We rely on each other's expertise and hold one another accountable. We feel empowered to share insights and identify opportunities for improvement. This open dialogue fosters trust within the team and enhances our product offerings.

Key Responsibilities


Oversee the lifecycle management of policies and procedures within the GxP Quality Management System (QMS) framework, ensuring QMS governance and supporting document creation, approval, and implementation strategies.


Facilitate Subject Matter Expert Councils and Communities of Practice necessary for the development and maintenance of compliant global QMS process documents.

Assess and report on the effectiveness of quality system deployment and drive continuous improvement initiatives based on stakeholder feedback.

Provide guidance and support for global information technology (IT) system implementations (e.g., eQMS).

Engage with all organizational levels to collaborate on key initiatives that drive desired QMS outcomes.

Qualifications

- Bachelor's degree in science or engineering; advanced degree preferred.
- 7 years of experience in Quality, Manufacturing, Engineering, or a related field.
- 3 years of experience in a design center and/or manufacturing environment.
- Comprehensive knowledge of international regulations and standards.
- Experience with regulatory agencies and/or notified bodies, including the ability to explain and defend processes and policies.
- Strong leadership capabilities, adept at managing multiple priorities.
- Excellent interpersonal skills, with the ability to communicate, influence, and negotiate within a complex organization.
- Proficient project management and technical writing skills.
- Willingness to travel as necessary.

Baxter is dedicated to providing flexible workplace options. Our policy includes a minimum of 3 days a week onsite, promoting in-person collaboration to support our mission.

We recognize that compensation is a vital consideration in your career decisions.

At Baxter, we are committed to equitable pay for all employees and strive for transparency in our compensation practices.

The estimated base salary for this position ranges from $128,000 to $176,000 annually. This range reflects anticipated compensation for the role.

Individual pay may vary based on location, skills, experience, and other relevant factors. This position may also qualify for discretionary bonuses and/or long-term incentives.


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 providing reasonable accommodations to individuals with disabilities globally.

If you require a reasonable accommodation due to a medical condition or disability during the application or interview process, please let us know the nature of your request along with your contact information.


Recruitment Fraud Notice


Baxter has identified incidents of employment scams where fraudulent parties impersonate Baxter employees or recruiters to solicit personal or financial information from job seekers.

To learn how to protect yourself, please review our Recruitment Fraud Notice.