Strategic Quality Compliance & Remediation Leader

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

Benefits offered by this job

Health and dental coverage start day 1

ESPP (Employee Stock Purchase Plan)

401(k) with company match

Paid time off 20–35 days

Job summary

Baxter International Inc. seeks a Director of Quality Compliance & Remediation Excellence to lead 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, and drive sustainable remediation programs. This role requires deep FDA/regulatory experience, a strong background in sterile manufacturing, and a track record leading remediation

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or a related field.
• 15+ years of experience in pharmaceutical manufacturing and Quality.
• 10+ years of leadership in Quality, Compliance, or Regulatory functions.

Responsibilities

• Lead regulatory compliance and inspection readiness activities 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 analysis, CAPA effectiveness, and quality system performance.
• Support sterility assurance, contamination control, aseptic processing, and microbiological risk management.
• Strengthen data integrity practices and promote a culture of quality, compliance, and continuous improvement.
• Serve as a trusted advisor to site and executive leadership on quality and compliance risks.

Skills

FDA inspections

Quality systems

CAPA

Data integrity

Cross-functional leadership

Education

Bachelors degree in Pharmacy/Cood/Eng/Life Sciences

Job description

Baxter International Inc. seeks a Director of Quality Compliance & Remediation Excellence to lead 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, and drive sustainable remediation programs. This role requires deep FDA/regulatory experience, a strong background in sterile manufacturing, and a track record leading remediation