at Baxter Healthcare Corporation in Deerfield, Illinois, United States
Job Description
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.
Your Role at Baxter
This is where your creativity addresses challenges
You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Director, Quality Compliance, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.
Your Team at Baxter
Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
What you'll be doing
Conducts segment management reviews with executive management
Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, EMA, and other relevant authorities.
Provide strategic leadership and oversight for the management of quality systems, including but not limited to document control, change control, deviation management, CAPA, training, and audits.
Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department. Leads regulatory inspections.
Collaborate with regulatory affairs teams to facilitate product registrations and submissions in compliance with regional and international regulations
Conduct regular risk assessments to identify potential compliance vulnerabilities and develop strategies to mitigate risks effectively. Monitor changes in laws, regulations, and industry trends to anticipate and address emerging compliance issues proactively.
Lead and participate in internal and external audits (ie clinical/preclinical, PV, and etc), inspections, and regulatory submissions, ensuring timely responses and resolution of any findings or observations.
Identified and leads continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability, and cost improvements.
Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
Collaborate cross-functionally with various departments, including Quality Assurance, Regulatory Affairs, Manufacturing, and R&D, to drive... For full info follow application link.
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.
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