Strategic Leader: Quality Compliance & Remediation

Baxter Healthcare; Deerfield (IL); On-site; USD 176,000 - 242,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee stock purchase plan (ESPP)

Paid time off

Paid holidays

Educational assistance

Commuting benefits

Employee discount program

Employee Assistance Program (EAP)

Childcare benefits

Job summary

Baxter Healthcare in Deerfield, IL, seeks a Director, Quality Compliance & Remediation Excellence to lead strategic quality across our pharmaceutical and sterile solutions network. You will partner with site and enterprise leaders to strengthen regulatory compliance and drive remediation programs that yield sustainable improvements across manufacturing operations.

This role requires deep FDA/regulatory experience, sterile manufacturing background, and a track record of leading remediation

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or related 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 interactions with regulators.
• Knowledge of cGMPs, investigations, CAPA, risk management, and data integrity.

Responsibilities

• Lead regulatory compliance and inspection readiness across pharma and sterile manufacturing sites.
• Support FDA/global authority inspections, regulatory responses and remediation.
• Drive complex compliance and remediation programs to closure.
• Provide expertise in investigations, CAPA effectiveness, and quality system performance.
• Support sterility assurance, contamination control, aseptic processing, and microbiological risk management.

Skills

Regulatory leadership

FDA inspections

Quality systems

Data integrity

Cross-functional collaboration

Education

Bachelor's degree in Pharmacy/Science/Engineering

Job description

Baxter Healthcare in Deerfield, IL, seeks a Director, Quality Compliance & Remediation Excellence to lead strategic quality across our pharmaceutical and sterile solutions network. You will partner with site and enterprise leaders to strengthen regulatory compliance and drive remediation programs that yield sustainable improvements across manufacturing operations.

This role requires deep FDA/regulatory experience, sterile manufacturing background, and a track record of leading remediation