Director, Quality Compliance & Remediation Excellence

This is where
your work makes a difference.

At Baxter, we believe every person - regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

As the Director, Quality Compliance & Remediation Excellence, you will provide strategic quality leadership across Baxter's 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 complex remediation programs that drive sustainable improvements across manufacturing operations.

This role is ideal for a leader with deep FDA and regulatory experience, a strong background in sterile pharmaceutical manufacturing, and a proven track record leading remediation efforts in highly regulated environments.

• Lead regulatory compliance and inspection readiness activities across pharmaceutical and sterile solutions 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 programs.
• 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.

• 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 experience within Quality, Compliance, or Regulatory functions.
• Experience leading FDA inspections and interacting directly with regulatory agencies.
• Proven success leading remediation programs associated with regulatory observations, Warning Letters, OAI classifications, Consent Decrees, or similar regulatory actions.
• Strong knowledge of cGMPs, Quality Systems, investigations, CAPA, risk management, and data integrity.
• Experience supporting sterile pharmaceutical manufacturing operations, including aseptic processing, sterility assurance, contamination control, injectable products, and/or IV solutions.
• Demonstrated ability to influence cross-functional stakeholders and drive sustainable compliance improvements.
• Ability to travel as needed to support pharmaceutical and sterile solutions manufacturing sites, regulatory inspections, and remediation activities.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $176,000 - $242,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and…