Director, Quality Compliance & Remediation Excellence

$176k - $242k

Baxter Healthcare

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

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Vacancy posted 2 days ago

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