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Director, Quality Compliance & Remediation Excellence

$176k - $242k

Baxter Healthcare

Deerfield, IL

Director-level quality leadership role overseeing regulatory compliance, inspection readiness, and remediation programs across Baxter's pharmaceutical and sterile manufacturing sites. Reports to senior leadership and partners with site teams to strengthen compliance, manage regulatory interactions, and drive sustainable quality improvements.

Responsibilities

  • Lead regulatory compliance and inspection readiness activities across multiple 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 root cause analysis, CAPA effectiveness, and quality system performance
  • Advise site and executive leadership on quality and compliance risks

Requirements

  • Bachelor's degree in Pharmacy, Chemistry, Microbiology, Engineering, or Life Sciences
  • 15+ years pharmaceutical manufacturing and Quality experience
  • 10+ years leadership in Quality, Compliance, or Regulatory functions
  • Proven success leading remediation programs for regulatory observations or Warning Letters
  • Strong knowledge of cGMPs, Quality Systems, CAPA, investigations, and data integrity
  • Experience with sterile pharmaceutical manufacturing, aseptic processing, and injectable products
  • Direct FDA inspection leadership and regulatory agency interaction experience

Compensation: $176,000 - $242,000 base annually

Apply
Vacancy posted 11 days ago
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