QMS Program Lead: Quality, Compliance & Readiness

Zvh; United States; On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

401(k) plan

Paid time off

Job summary

Baxter is seeking a Quality Management System Program Leader to oversee a portfolio of quality programs, including investigations, customer complaints, change control, APQR, and management review. You will establish governance, develop scoring and escalation processes, and drive risk-based prioritization across functions to ensure compliance and operational excellence.

The role emphasizes data-driven decision making, leadership of quality professionals, and proactive inspection readiness.

Qualifications

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

cGMP regulations

Quality system governance

Investigations

CAPA

Change control

Regulatory inspections

Data integrity

Leadership

Education

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

Tools

TrackWise

Power BI

Tableau

Smartsheet

Advanced Excel

Job description

Baxter is seeking a Quality Management System Program Leader to oversee a portfolio of quality programs, including investigations, customer complaints, change control, APQR, and management review. You will establish governance, develop scoring and escalation processes, and drive risk-based prioritization across functions to ensure compliance and operational excellence.

The role emphasizes data-driven decision making, leadership of quality professionals, and proactive inspection readiness.