Senior Quality Investigation Lead

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

Benefits offered by this job

Health & dental coverage

401(k) with company match

Paid time off

Job summary

Baxter is seeking a Senior Quality Investigation Lead in the United States. You will independently lead high-risk, systemic investigations, partnering with leaders and technical experts to evaluate evidence, assess product impact, and develop corrective actions.

You will coach investigators and strengthen the program through calibration and continuous improvement efforts. You will communicate findings to senior leadership and participate in internal and regulatory inspections, ensuring adherence

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, or related field.
• 5+ years in regulated pharmaceutical/biotech/medical device operations.
• 3+ years leading formal investigations of quality events.
• Experience with cGMP, GxP, CAPA, data integrity, and investigation methodologies.
• Strong writing, analytical reasoning, facilitation, and leadership skills.
• Experience communicating to senior leadership, auditors, inspectors, and cross-functional stakeholders.
• Proficiency with eQMS (TrackWise) and data analysis/reporting tools.

Responsibilities

• Lead high-risk, systemic investigations from initiation to Quality approval.
• Develop investigation strategies, evidence plans, risk assessments, and decision frameworks.
• Direct multidisciplinary teams through evidence collection, hypothesis testing, and analysis.
• Evaluate data from quality, manufacturing, lab, supplier, engineering, and electronics systems to identify root causes.
• Facilitate senior-level discussions on findings, risk, and corrective actions.
• Prepare investigation reports, executive summaries, and technical conclusions for audits and inspections.
• Mentor investigators and support calibration activities across the organization.

Skills

Subject matter expert in quality

cGMP regulations

Data analysis

Project leadership

Senior stakeholder communication

Mentoring investigators

Education

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

Advanced degree preferred

Tools

TrackWise

Data analysis tools

Job description

Baxter is seeking a Senior Quality Investigation Lead in the United States. You will independently lead high-risk, systemic investigations, partnering with leaders and technical experts to evaluate evidence, assess product impact, and develop corrective actions.

You will coach investigators and strengthen the program through calibration and continuous improvement efforts. You will communicate findings to senior leadership and participate in internal and regulatory inspections, ensuring adherence