QMS Program Leader – Quality & Compliance

Baxter International Inc.; Round Lake (IL); Presencial; USD 112.000 - 154.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical and dental coverage

401(k) with company matching

Paid time off 20–35 days

Descripción de la vacante

Baxter International Inc. is seeking a Quality Management System (QMS) Program Leader in Round Lake, IL.

You will oversee a portfolio of quality programs ensuring product quality, regulatory compliance, and operational excellence across investigations, complaints, change control, APQR, and management review. In this high-visibility role, you will build governance, strengthen accountability, and lead high-performing teams to address risks proactively.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality governance

Leadership

Regulatory compliance

Data analysis

Investigations

Change control

CAPA

Communication

Educación

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

Advanced degree (preferred)

Herramientas

TrackWise

Power BI

Tableau

Smartsheet

Advanced Excel reporting

Descripción del empleo

Baxter International Inc. is seeking a Quality Management System (QMS) Program Leader in Round Lake, IL.

You will oversee a portfolio of quality programs ensuring product quality, regulatory compliance, and operational excellence across investigations, complaints, change control, APQR, and management review. In this high-visibility role, you will build governance, strengthen accountability, and lead high-performing teams to address risks proactively.