QMS Program Leader: Quality & Compliance Strategist

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

Benefits offered by this job

Health and dental coverage

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid time off 20–35 days depending on/

Parental leave

Job summary

Baxter International is seeking a QMS Program Leader in Round Lake, IL to oversee quality system programs, investigations, customer complaints, and change control. You will set governance, drive risk-based priorities, and lead cross-functional teams to ensure compliance and ongoing inspection readiness.

The role emphasizes data-driven decision making, performance metrics, and cross-functional collaboration with Manufacturing, Engineering, Regulatory Affairs, and Quality Control to sustain

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.

Responsibilities

• 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.

Skills

Leadership

Data analysis

Regulatory readiness

Quality data trends

cGMP knowledge

Quality governance

Education

Bachelor's degree in Science/Engineering/Life Sciences/Quality/Regulatory

Advanced degree (preferred)

CMQ/OE / CQA / CQE / Six Sigma (certification)

Tools

TrackWise

Power BI

Tableau

Smartsheet

Excel

Job description

Baxter International is seeking a QMS Program Leader in Round Lake, IL to oversee quality system programs, investigations, customer complaints, and change control. You will set governance, drive risk-based priorities, and lead cross-functional teams to ensure compliance and ongoing inspection readiness.

The role emphasizes data-driven decision making, performance metrics, and cross-functional collaboration with Manufacturing, Engineering, Regulatory Affairs, and Quality Control to sustain