Manager, QMS

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

As the Quality Management System (QMS) Program Leader, you will oversee a portfolio of quality system programs that are essential to maintaining product quality, regulatory compliance, and operational excellence. You will serve as the site leader for investigation management while providing governance and strategic direction across customer complaints, change control, APQR, and management review processes.

In this highly visible leadership role, you will establish effective quality governance, strengthen organizational accountability, develop high-performing teams, and ensure risks are identified, evaluated, and addressed proactively. Success will be measured through improved process performance, inspection readiness, data-driven decision making, and the sustained effectiveness of quality systems that support patients, customers, and business objectives.

What You'll Be Doing

• Lead the site Quality Management System portfolio, providing oversight of investigations, customer complaints, change control, APQR, management review, and related quality programs.
• Establish governance frameworks, performance measures, escalation processes, and risk-based priorities that strengthen compliance and operational effectiveness.
• Drive meaningful analysis of quality data and trends to identify emerging risks, recurring issues, systemic opportunities, and preventive actions across the business.
• Partner with Manufacturing, Engineering, Quality Control, Regulatory Affairs, Validation, Supplier Quality, and other cross-functional teams to ensure timely, evidence-based decisions and sustainable solutions.
• Develop and coach Quality professionals while fostering accountability, capability growth, and a culture of continuous improvement.
• Monitor quality performance through integrated scorecards and reporting, using metrics to improve process health, effectiveness, and organizational outcomes.
• Represent quality system programs during internal audits, customer assessments, and regulatory inspections while maintaining ongoing inspection readiness.

What You'll Bring

Required Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Regulatory Affairs, or a related technical discipline.
• 8+ years of progressive experience in Quality, regulated manufacturing, compliance, laboratory operations, engineering, product surveillance, or similar environments within pharmaceutical, biotechnology, medical device, or other highly regulated industries.
• 3+ years of leadership experience managing people, leading quality programs, or directing significant cross-functional quality initiatives.
• Demonstrated expertise in cGMP regulations, quality system governance, investigations, CAPA, customer complaints, change control, quality risk management, and data integrity principles.
• Proven ability to analyze complex quality data, identify trends, assess risk, and translate insights into business decisions and continuous improvement actions.
• Experience leading regulatory inspection readiness activities and presenting quality performance, risks, and recommendations to senior leadership.

Preferred Qualifications

• Advanced degree in a scientific, engineering, quality, or related discipline.
• Experience leading multiple Quality Management System programs within pharmaceutical, biotechnology, or medical device manufacturing environments.
• Experience with FDA, Health Canada, or other global regulatory authority inspections and responses.
• Proficiency with electronic Quality Management Systems (eQMS) such as TrackWise and analytics tools including Power BI, Tableau, Smartsheet, or advanced Excel reporting.
• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Six Sigma Black Belt, RAC, or comparable professional certification.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. …