Senior Quality Investigation Lead

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

Benefits offered by this job

Discretionary bonuses

Health and wellbeing benefits

Paid time off 20-35 days

Job summary

Baxter International in Round Lake, IL is seeking a Senior Quality Investigation Lead to serve as a subject matter expert in Baxter's Quality-led investigation program. You will independently lead high-risk investigations across functions, evaluate evidence, determine root causes, and develop corrective actions.

You will mentor investigators, calibrate cases, and contribute to program improvements while ensuring compliance with patient safety and regulatory expectations.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or a related technical discipline is required or equivalent regulated-industry experience.
• 5+ years of progressive experience within pharmaceutical, biotechnology, medical device, manufacturing, or Quality operations in a regulated environment.
• 3+ years of experience leading formal investigations, including ownership of complex, recurring, systemic, or high-risk quality events.
• Demonstrated expertise in cGMP regulations, Good Documentation Practices, quality risk management, CAPA systems, data integrity, and investigation methodologies.

Responsibilities

• Lead complex, high-risk investigations from initiation through independent Quality approval, ensuring timely and comprehensive resolution.
• Develop investigation strategies, evidence plans, risk assessments, and decision frameworks that support accurate root cause determination and product impact evaluation.
• Direct multidisciplinary teams through evidence collection, technical analysis, hypothesis testing, and scientific problem-solving activities.
• Evaluate quality, manufacturing, laboratory, supplier, engineering, and electronic system data to identify root causes and opportunities for preventive action.
• Facilitate senior-level discussions that drive alignment on investigation findings, risk assessments, product impact evaluations, and corrective action strategies.
• Author and present investigation reports, executive summaries, and technical conclusions during internal audits and regulatory inspections.

Skills

cGMP regulations

Good Documentation Practices

CAPA systems

data integrity

investigation methodologies

technical writing

facilitation

project leadership

coaching and training

conflict resolution

Education

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

Advanced degree in Science, Engineering, Pharmacy, Life Sciences, Quality, or related discipline

Tools

TrackWise

data analysis tools

Job description

Baxter International in Round Lake, IL is seeking a Senior Quality Investigation Lead to serve as a subject matter expert in Baxter's Quality-led investigation program. You will independently lead high-risk investigations across functions, evaluate evidence, determine root causes, and develop corrective actions.

You will mentor investigators, calibrate cases, and contribute to program improvements while ensuring compliance with patient safety and regulatory expectations.