Senior Remediation Leader - Quality & Compliance

Baxter; Round Lake (IL); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Medical and dental coverage from day1

401(k) Retirement Savings Plan with 2x

Employee Stock Purchase Plan (ESPP)

Paid time off 20 to 35 days

Job summary

Baxter International in Round Lake, IL, is seeking a Remediation Lead to provide senior Quality leadership for complex remediation programs. You will translate regulatory observations into practical, risk-based plans that protect product quality and patient safety.

You will collaborate across Quality, Manufacturing, Regulatory Affairs, IT, and supply chain, establish governance, manage interdependencies, and drive evidence-based closure.

Qualifications

• Bachelor's degree in a technical field and regulatory experience.
• Proven leadership of cross-functional remediation and quality systems.
• Experience supporting FDA or global health-authority inspections.

Responsibilities

• Lead remediation programs, translating findings into actionable plans.
• Establish governance, accountability, and milestone tracking across workstreams.
• Provide independent quality oversight and ensure defensible closure.
• Coordinate regulatory responses and readiness materials.
• Drive cross-functional execution across Quality, Manufacturing, Regulatory, IT, and Supply Chain.

Skills

Quality leadership

Regulatory inspections experience

Program management

Cross-functional collaboration

Data integrity / CAPA

Communication skills

Education

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

Tools

Electronic Quality Management Systems

Regulatory reporting tools

Job description

Baxter International in Round Lake, IL, is seeking a Remediation Lead to provide senior Quality leadership for complex remediation programs. You will translate regulatory observations into practical, risk-based plans that protect product quality and patient safety.

You will collaborate across Quality, Manufacturing, Regulatory Affairs, IT, and supply chain, establish governance, manage interdependencies, and drive evidence-based closure.