QMS Program Leader: Quality Governance & Compliance

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

Ventajas ofrecidas por este puesto de trabajo

Comprehensive benefits

401(k) with company match

Paid time off 20–35 days

Descripción de la vacante

Baxter International is seeking a QMS Program Leader to oversee quality system programs ensuring product quality, regulatory compliance, and operational excellence at the Round Lake site. You will govern investigations, customer complaints, change control, and APQR while driving governance, accountability, and a culture of continuous improvement.

The role requires strong expertise in cGMP, data integrity, and regulatory inspections, plus leadership of cross-functional teams to deliver sustained

Formación

• Bachelor's degree in a science/engineered/regulatory field required
• 8+ years in quality/regulatory environments within regulated industries
• 3+ years leadership experience managing people and quality programs
• Demonstrated expertise in cGMP, CAPA, change control, investigations, data integrity

Responsabilidades

• Lead site Quality Management System portfolio including investigations, customer complaints, change control, APQR, and management review
• Establish governance frameworks, KPIs, escalation processes, and risk-based priorities
• Drive analysis of quality data to identify risks, trends, and preventive actions
• Partner with Manufacturing, Engineering, Regulatory Affairs, Validation, and supplier quality teams
• Develop and coach quality professionals; foster accountability and continuous improvement
• Monitor quality performance via scorecards and reporting to improve process health
• Represent quality during audits, customer assessments, and regulatory inspections

Conocimientos

Quality leadership

Data analysis

Regulatory knowledge

Cross-functional collaboration

Communication

People management

Educación

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

Herramientas

TrackWise

Power BI

Tableau

Smartsheet

Excel (advanced)

Descripción del empleo

Baxter International is seeking a QMS Program Leader to oversee quality system programs ensuring product quality, regulatory compliance, and operational excellence at the Round Lake site. You will govern investigations, customer complaints, change control, and APQR while driving governance, accountability, and a culture of continuous improvement.

The role requires strong expertise in cGMP, data integrity, and regulatory inspections, plus leadership of cross-functional teams to deliver sustained