Manager, Quality

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 Team at Baxter:

Within Quality Ops, 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 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.

• Responsible for ensuring that the company's operations and activities comply with all relevant laws, regulations, and industry standards within the segment. The role includes ensuring the implementation and maintenance of robust quality systems in accordance with regulatory requirements and industry standards. You will work closely with various departments, including legal, regulatory affairs, quality assurance, and operations, to develop, implement, and maintain effective compliance programs and processes.
• Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, 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.
• Training and
  
  Education:
  
  Design and deliver comprehensive compliance training programs for employees at all levels to promote awareness of compliance obligations and foster a culture of integrity and ethical conduct within the organization.
• Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department. Manages regulatory inspections.
• Risk Assessment and Mitigation:
  Conduct regular 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.
• Monitoring and Auditing:
  Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify areas for improvement. Lead and participate in internal and external audits, inspections, ensuring timely responses and resolution of any findings or observations.
• Investigations and Remediation:
  Lead investigations into compliance incidents, allegations of misconduct, or violations of policies and regulations. Implement corrective actions and remediation plans to address identified issues and prevent recurrence.
• Collaborate cross-functionally with various departments, including Quality…