QMS Program Leader - Quality & Compliance

Milwaukee Succeeds; Round Lake (IL); On-site; USD 112,000 - 154,000; Full time

Job summary

Baxter in the US is seeking a Quality Management System (QMS) Program Leader to oversee essential quality programs ensuring product quality, regulatory compliance, and operational excellence. You will serve as the site leader for investigation management and provide governance across customer complaints, change control, APQR, and management review processes.

In this highly visible role, you will build effective governance, develop high-performing teams, and drive data-driven decisions to sustain

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or Regulatory Affairs.
• 8+ years in quality, regulated manufacturing, or related fields.
• 3+ years in leadership, managing people or cross-functional quality initiatives.
• Experience with cGMP regulations, quality governance, CAPA, change control, data integrity.
• Ability to analyze quality data, identify trends, and translate into actions.
• Experience with regulatory inspection readiness and presenting to senior leadership.

Responsibilities

• Lead the site QMS portfolio including investigations, complaints, change control, APQR, and management review.
• Establish governance, metrics, escalation, and risk-based priorities.
• Analyze quality data to identify risks and preventive actions.
• Collaborate with Manufacturing, Engineering, Regulatory, and other teams.
• Develop and coach Quality professionals and promote continuous improvement.
• Monitor performance via scorecards and reports to improve processes.
• Represent quality during internal audits, customer assessments, and inspections.

Skills

Quality leadership

Data-driven decision making

Risk management

Education

Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, Regulatory Affairs, or related technical discipline

ASQ CMQ/OE or equivalent certification

Tools

TrackWise

Power BI

Tableau

Smartsheet

Advanced Excel

Job description

Baxter in the US is seeking a Quality Management System (QMS) Program Leader to oversee essential quality programs ensuring product quality, regulatory compliance, and operational excellence. You will serve as the site leader for investigation management and provide governance across customer complaints, change control, APQR, and management review processes.

In this highly visible role, you will build effective governance, develop high-performing teams, and drive data-driven decisions to sustain