Director, Quality Compliance & Remediation Excellence
Baxter International Inc.
Summary
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.
Job description
What You'll Be Doing
- 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.
What You'll Bring
- 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.
Requirements
- 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.
Benefits
- Medical, Dental & Vision
- Life Insurance
- Accident Insurance
- Short-term Disability
- Long-term Disability
- Business Travel Accident Insurance
- Employee Stock Purchase Plan
- 401(k) Matching
- Flexible Spending Accounts
- Educational Assistance
- Paid Holidays
- Paid Time Off
- Family and Medical Leave
- Paid Parental Leave
- Commuting Benefits
- Employee Discount Program
- Employee Assistance Program
- Childcare Benefits
Company overview
Baxter International Inc. is an American multinational healthcare company headquartered in Deerfield, Illinois, founded in 1931. As a leading global medical device manufacturer, Baxter specializes in developing and producing essential medical products for treating chronic and acute medical conditions. The company operates across three primary business segments: Medical Products and Therapies, Healthcare Systems and Technologies, and Pharmaceuticals. Baxter's extensive product portfolio includes intravenous (IV) solutions, infusion pumps, dialysis equipment for kidney disease treatment, surgical technologies, and hospital pharmaceuticals. With approximately 38,000 employees worldwide and annual revenues exceeding $10 billion, Baxter plays a critical role in global healthcare infrastructure. The company is particularly known for its leadership in IV fluid production, manufacturing approximately 60% of the intravenous fluids used in the United States. Baxter's innovations include pioneering developments in artificial kidney technology and advanced surgical products, serving healthcare providers across more than 100 countries. The company maintains a strong commitment to research and development, investing significantly in medical technology advancements that improve patient outcomes and healthcare delivery efficiency.