Senior Remediation Leader - Quality & Compliance

Baxter International; Round Lake (IL); On-site; USD 112,000 - 154,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid time off

Job summary

Baxter International is seeking a Remediation Lead at Round Lake Drug Delivery to provide senior Quality leadership for complex remediation programs. You will translate regulatory observations and quality gaps into practical, risk-based plans that deliver sustainable compliance, protect product quality, and support patient safety.

The role requires cross-functional collaboration with Quality, Manufacturing, Engineering, and Regulatory Affairs, leading governance and reporting to site and

Qualifications

• Bachelor’s degree or higher in a technical field related to pharma/biotech/regulatory.
• 8+ years in regulated manufacturing with quality/regulatory experience.
• Proven leadership of cross-functional remediation programs.
• Experience supporting FDA or global health authority inspections and remediation.
• Strong knowledge of cGMPs, Quality Systems, investigations, CAPA, change control.
• Experience in sterile manufacturing and related processes.

Responsibilities

• Lead development, integration, and execution of remediation strategies.
• Define workstreams, owners, milestones, and evidence of closure.
• Maintain a risk-based remediation master plan and governance cadence.
• Provide Quality oversight to ensure plans are sound and defensible.
• Drive cross-functional execution across Quality, Manufacturing, Engineering, and more.
• Coach leads on problem definition, evidence-based closure, and executive updates.

Skills

Leadership

Regulatory knowledge

Program governance

Cross-functional collaboration

Communication

Education

Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, Quality

Master's degree in scientific, engineering, quality, regulatory, or business

Tools

eQMS

Regulatory dashboards

Job description

Baxter International is seeking a Remediation Lead at Round Lake Drug Delivery to provide senior Quality leadership for complex remediation programs. You will translate regulatory observations and quality gaps into practical, risk-based plans that deliver sustainable compliance, protect product quality, and support patient safety.

The role requires cross-functional collaboration with Quality, Manufacturing, Engineering, and Regulatory Affairs, leading governance and reporting to site and