QMS Program Leader: Quality & Compliance

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

Benefits offered by this job

Health insurance

401(k) with company match

Employee stock purchase plan (ESPP)

Job summary

Baxter is seeking a Quality Management System Program Leader in Illinois to oversee essential quality programs and governance across investigations, complaints, and change control. You will lead a high-visibility team, drive risk-based improvements, and sustain inspection readiness in a regulated manufacturing environment.

The role emphasizes collaboration with manufacturing, engineering, and regulatory affairs, with a focus on data-driven decisions, CAPA implementation, and continuous quality

Qualifications

• 8+ years in Quality, regulated manufacturing, or similar environments.
• 3+ years of leadership managing people and cross-functional quality initiatives.
• Experience with cGMP, quality governance, investigations, CAPA, change control, and data integrity.
• Regulatory inspection readiness experience and presenting quality performance to leadership.
• Ability to analyze complex data and translate insights into actions for improvement.

Responsibilities

• Lead the site Quality Management System portfolio, overseeing investigations, customer complaints, change control, APQR, and management reviews.
• Establish governance frameworks, performance measures, escalation processes, and risk-based priorities.
• Drive analysis of quality data and trends to identify risks, recurring issues, and preventive actions.
• Partner with Manufacturing, Engineering, Regulatory Affairs, and other functions to ensure timely, evidence-based decisions.
• Develop and coach Quality professionals and foster accountability and continuous improvement.
• Monitor quality performance with scorecards and reporting to improve process health and outcomes.
• Represent quality during internal audits, customer assessments, and regulatory inspections.

Skills

Quality leadership

Regulatory compliance

cGMP knowledge

Data analysis

Cross-functional collaboration

Audit readiness

Risk management

Leadership

Education

Bachelor's degree

Tools

TrackWise

Power BI

Tableau

Smartsheet

Excel

Job description

Baxter is seeking a Quality Management System Program Leader in Illinois to oversee essential quality programs and governance across investigations, complaints, and change control. You will lead a high-visibility team, drive risk-based improvements, and sustain inspection readiness in a regulated manufacturing environment.

The role emphasizes collaboration with manufacturing, engineering, and regulatory affairs, with a focus on data-driven decisions, CAPA implementation, and continuous quality