Quality Compliance & Regulatory Excellence Director

Regulatory Jobs; Deerfield (IL); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Health and dental benefits

401(k) with company match

Employee stock purchase plan (ESPP)

Paid time off

Job summary

Baxter is seeking a Director of Quality Compliance & Remediation Excellence to provide strategic quality leadership across its pharmaceutical and sterile solutions manufacturing network.

You will partner with site and enterprise leaders to strengthen regulatory compliance, ensure inspection readiness, provide independent quality oversight, and lead remediation programs driving sustainable improvements across operations.

Qualifications

• Bachelor's degree required in a relevant field.
• 15+ years of experience in pharmaceutical manufacturing and Quality.
• 10+ years of leadership in Quality, Compliance, or Regulatory functions.
• Experience leading FDA inspections and direct interaction with regulatory agencies.
• Proven success leading remediation programs tied to regulatory observations and enforcement actions.

Responsibilities

• Lead regulatory compliance and inspection readiness across pharmaceutical and sterile manufacturing sites.
• Support FDA and global health authority inspections, regulatory responses, and remediation efforts.
• Drive complex compliance and remediation programs to sustainable closure.
• Provide expertise in investigations, root cause analyses, CAPA effectiveness, and QMS performance.
• Support sterility assurance, contamination control, aseptic processing, and microbiological risk management.

Skills

Regulatory leadership

Quality systems

FDA inspections

Cross-functional leadership

Data integrity

Root cause analysis

Education

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

Job description

Baxter is seeking a Director of Quality Compliance & Remediation Excellence to provide strategic quality leadership across its pharmaceutical and sterile solutions manufacturing network.

You will partner with site and enterprise leaders to strengthen regulatory compliance, ensure inspection readiness, provide independent quality oversight, and lead remediation programs driving sustainable improvements across operations.