Senior Quality Investigation Lead

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

Benefits offered by this job

Health benefits

401(k) with company match

Employee Stock Purchase Plan (ESPP)

Paid holidays and PTO 20–35 days

Commuting benefits

Job summary

Baxter International is seeking a Senior Quality Investigation Lead to steer high-risk, cross-functional investigations within our quality-led program. You will evaluate evidence, determine root causes, and develop preventive actions while coaching teams to strengthen the overall investigation capability.

Strong experience with cGMP, CAPA, and eQMS systems like TrackWise is required. This role focuses on ensuring patient safety and regulatory compliance in a fast-paced environment.

Qualifications

• 5+ years of progressive experience in regulated pharma/biotech/medical device environments.
• 3+ years leading formal investigations, including high-risk events.
• Demonstrated expertise in cGMP regulations, GDPL, CAPA, data integrity, and investigation methodologies.
• Strong writing, analytical, facilitation, and cross-functional collaboration skills.
• Experience communicating with senior leadership, auditors, and inspectors.

Responsibilities

• Lead complex, high-risk investigations from initiation to Quality approval.
• Develop strategies, evidence plans, risk assessments, and decision frameworks for root cause and product impact.
• Direct multidisciplinary teams through evidence collection, analysis, and hypothesis testing.
• Evaluate data from quality, manufacturing, lab, supplier, engineering, and systems to identify root causes and preventive actions.
• Facilitate senior-level discussions to align on findings, risk, and corrective actions.
• Prepare and present investigation reports, exec summaries, and conclusions for audits and inspections.
• Mentor investigators, calibrate cases, and support capability development across the organization.

Skills

Quality investigations leadership

cGMP knowledge

Data analysis

Technical writing

Facilitation and coaching

Education

Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related technical discipline

Tools

TrackWise

Job description

Baxter International is seeking a Senior Quality Investigation Lead to steer high-risk, cross-functional investigations within our quality-led program. You will evaluate evidence, determine root causes, and develop preventive actions while coaching teams to strengthen the overall investigation capability.

Strong experience with cGMP, CAPA, and eQMS systems like TrackWise is required. This role focuses on ensuring patient safety and regulatory compliance in a fast-paced environment.