Senior Quality Investigations Lead – Cross-Functional

Baxter; Round Lake (IL); On-site; USD 96,000 - 132,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Baxter International in Round Lake, IL seeks a Senior Quality Investigation Lead to spearhead high-risk, cross-functional investigations within its quality-led program. You will evaluate evidence, determine root causes, and implement effective CAPA actions to protect patient safety and ensure regulatory compliance.

You will coach investigators, calibrate cases, and drive continuous improvement while communicating complex technical findings to leadership and auditors.

Qualifications

• Bachelor's degree in a related technical discipline.
• 5+ years of experience in regulated pharmaceutical/biotech/medical device environments.
• 3+ years leading formal investigations of quality events.
• Proficiency with cGMP, GxP, CAPA, data integrity, and investigation methodologies.
• Strong technical writing and communication to senior leadership.

Responsibilities

• Lead complex, high-risk investigations from initiation to Quality approval.
• Develop investigation strategies, risk assessments, and decision frameworks.
• Direct multidisciplinary teams through evidence collection, analysis, and hypothesis testing.
• Evaluate data from quality, manufacturing, labs, suppliers, and engineering for root causes.
• Facilitate senior-level discussions on findings, risk, and corrective actions.
• Author and present reports during audits and regulatory inspections.
• Mentor investigators and support calibration and qualification programs.

Skills

Analytical reasoning

Technical writing

Project leadership

Facilitation

Cross-functional collaboration

Education

Bachelor's degree in Science/Engineering/Pharmacy

Tools

TrackWise

Job description

Baxter International in Round Lake, IL seeks a Senior Quality Investigation Lead to spearhead high-risk, cross-functional investigations within its quality-led program. You will evaluate evidence, determine root causes, and implement effective CAPA actions to protect patient safety and ensure regulatory compliance.

You will coach investigators, calibrate cases, and drive continuous improvement while communicating complex technical findings to leadership and auditors.