Director, Quality Compliance & Remediation Excellence
About The Position
The Director, Quality Compliance & Remediation Excellence provides strategic quality leadership across Baxter’s pharmaceutical and sterile solutions manufacturing network. The role partners with site and enterprise leaders to strengthen regulatory compliance, maintain inspection readiness, provide independent quality oversight, and lead complex remediation programs that drive sustainable improvements across manufacturing operations. This role is suited to a leader with deep FDA and regulatory experience, a strong background in sterile pharmaceutical manufacturing, and a proven record of leading remediation efforts in highly regulated environments. The position requires travel as needed to manufacturing sites and to support regulatory inspections and remediation activities.
Requirements
- Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, or a related field.
- At least 15 years of experience in pharmaceutical manufacturing and Quality.
- At least 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.
- 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.
Responsibilities
- 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.
- Advise site and executive leadership on quality and compliance risks.
- Travel as needed to support manufacturing sites, regulatory inspections, and remediation activities.
Benefits
- Medical and dental coverage starting on day one
- Basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount
- 401(k) Retirement Savings Plan with employee contributions and company matching
- Flexible Spending Accounts
- Educational assistance programs
- Paid holidays
- Paid time off ranging from 20 to 35 days based on length of service
- Family and medical leaves of absence
- Paid parental leave
- Commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- Childcare benefits
- May be eligible for discretionary bonuses, commission, and/or long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Director
