Senior Quality Investigation Lead

Baxter International; Round Lake (IL); Vor Ort; USD 96.000 - 132.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Life insurance

Disability insurance

ESPP

401(k)

Paid time off

Zusammenfassung

Baxter International is seeking a Senior Quality Investigation Lead to independently manage high-risk investigations and strengthen the quality program. You will evaluate evidence, assess product impact, and drive corrective actions across cross-functional teams to support patient safety and regulatory expectations.

Lead investigations, coach teams, calibrate cases, and present findings during audits and inspections. Strong cGMP knowledge and TrackWise experience are essential for success.

Qualifikationen

• Bachelor’s degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related field.
• 5+ years in regulated environments (pharma/biotech/medical devices).
• 3+ years leading formal investigations of quality events.
• Expertise in cGMP, GDP, CAPA, data integrity, and investigation methods.
• Ability to evaluate complex evidence and determine defensible root causes.

Aufgaben

• Lead high-risk, cross-functional investigations from initiation to Quality approval.
• Develop strategies, risk assessments, and decision frameworks for root cause analysis.
• Direct multidisciplinary teams through evidence collection, analysis, and testing.
• Evaluate quality, manufacturing, lab, supplier, and engineering data for root causes.
• Facilitate senior-level discussions on findings, risk, and corrective actions.
• Author investigation reports and participate in audits and inspections.

Kenntnisse

Technical writing

Analytical reasoning

Facilitation

Project leadership

Coaching

Conflict resolution

Communication to leadership

Data analysis tools

Ausbildung

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

Tools

TrackWise

Jobbeschreibung

Baxter International is seeking a Senior Quality Investigation Lead to independently manage high-risk investigations and strengthen the quality program. You will evaluate evidence, assess product impact, and drive corrective actions across cross-functional teams to support patient safety and regulatory expectations.

Lead investigations, coach teams, calibrate cases, and present findings during audits and inspections. Strong cGMP knowledge and TrackWise experience are essential for success.