Senior Quality Investigation Lead

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

Benefits offered by this job

Health and dental coverage

401(k) with company matching

Employee stock purchase plan (ESPP)

Job summary

Baxter is seeking a Senior Quality Investigation Lead to independently manage high-risk, systemic investigations across manufacturing, laboratory, and engineering domains. You will drive evidence-based decisions, CAPA strategies, and cross-functional collaboration to protect patient safety and regulatory compliance.

You will coach junior staff, present findings to senior leadership, and continuously improve the investigation program with robust documentation and risk management.

Qualifications

• Bachelor’s degree or equivalent in a regulated scientific/engineering field.
• 5+ years in pharma/biotech/medical device Quality operations in a regulated setting.
• 3+ years leading formal investigations of high-risk quality events.
• Proficient with cGMP, GxP, and data integrity practices.
• Experience evaluating complex technical evidence and root causes.

Responsibilities

• Lead high-risk, cross-functional investigations from intake to Quality approval.
• Define risk, scope, evidence strategy, milestones and escalation needs.

Skills

cGMP regulations

GxP documentation

CAPA systems

data integrity

investigation methodologies

technical writing

analytical reasoning

facilitation

project leadership

coaching

conflict resolution

stakeholder communication

Education

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

Tools

TrackWise

Job description

Baxter is seeking a Senior Quality Investigation Lead to independently manage high-risk, systemic investigations across manufacturing, laboratory, and engineering domains. You will drive evidence-based decisions, CAPA strategies, and cross-functional collaboration to protect patient safety and regulatory compliance.

You will coach junior staff, present findings to senior leadership, and continuously improve the investigation program with robust documentation and risk management.