Senior Quality Investigation Lead

Baxter International; Round Lake (IL); On-site; USD 88,000 - 121,000; Full time

Benefits offered by this job

Health and dental benefits

401(k) with company match

Paid time off 20–35 days

Job summary

Baxter International is seeking a Senior Quality Investigation Lead in Round Lake, IL to drive high-risk, cross-functional quality investigations and ensure regulatory alignment.

You will lead evidence collection, perform root cause analysis, and develop corrective actions, coaching investigators and coordinating with leaders to uphold patient safety and compliance across the organization.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline.
• 5+ years of regulated-industry experience in pharmaceutical/biotech/manufacturer quality ops.
• 3+ years leading formal investigations of high-risk quality events.
• Expertise in cGMP, Good Documentation Practices, quality risk management, CAPA, data integrity, and investigation methodologies.
• Ability to evaluate complex evidence, determine root causes, and develop durable corrective actions.
• Strong technical writing, analytical reasoning, facilitation, and leadership skills.
• Experience communicating to senior leadership, auditors, inspectors, and cross-functional stakeholders.
• Proficiency with eQMS such as TrackWise and data analysis/reporting tools.

Responsibilities

• Lead complex, high-risk investigations from initiation through independent Quality approval.
• Develop strategies, evidence plans, risk assessments, and decision frameworks for root cause and product impact evaluation.
• Direct multidisciplinary teams through evidence collection, analysis, and hypothesis testing.
• Evaluate quality, manufacturing, lab, supplier, engineering, and electronic system data to identify root causes.
• Facilitate senior-level discussions that drive alignment on findings, risk, product impact, and corrective actions.
• Author and present investigation reports, executive summaries, and technical conclusions during audits and inspections.
• Mentor investigators, contribute to calibration activities, and support investigation capability development.

Skills

cGMP regulations

Data integrity

Root cause analysis

Quality risk management

CAPA systems

eQMS TrackWise

Analytical reasoning

Project leadership

Coaching

Regulatory communication

Education

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

Tools

TrackWise

Job description

Baxter International is seeking a Senior Quality Investigation Lead in Round Lake, IL to drive high-risk, cross-functional quality investigations and ensure regulatory alignment.

You will lead evidence collection, perform root cause analysis, and develop corrective actions, coaching investigators and coordinating with leaders to uphold patient safety and compliance across the organization.