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Associate Director, Quality Compliance

https://www.baxter.com/ Logo

Baxter

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Location:
United States , Round Lake

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Contract Type:
Not provided

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Salary:

152000.00 - 209000.00 USD / Year

Job Description:

The Associate Director of Quality Compliance supports the site’s Quality Management System (QMS) and compliance programs across the Round Lake Drug Delivery network. This role provides operational leadership for audits, training, documentation, change control, and inspection readiness activities.

Job Responsibility:

  • Lead day‑to‑day activities within the site’s Quality Compliance programs
  • Support implementation of sitewide compliance strategy, policies, and standardization initiatives
  • Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
  • Serve as back‑room or front‑room support during inspections
  • Lead internal audits, supplier audits, and follow‑up activities
  • Assist in evaluating regulatory updates and enforcement trends
  • Oversee controlled documentation processes
  • Manage training system execution
  • Lead change control processes
  • Lead or support remediation teams focused on resolving compliance gaps
  • Work closely with QA Ops, Engineering, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs
  • Manage and develop Quality Compliance staff

Requirements:

  • Bachelor’s degree in science or engineering required
  • advanced degree preferred
  • 10+ years of experience in Quality Compliance/Quality Systems
  • 3–5 years leadership
  • Recent pharmaceutical manufacturing experience is required
  • Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
  • Proven ability to lead audits, manage documentation systems, and drive compliance improvements
What we offer:
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • 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

Additional Information:

Job Posted:
March 22, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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