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FDA Inspection Lead — CAPA, HHE & Regulatory Readiness
Job in
North Bothell Area, Snohomish County, Washington, 98021, USA
Listed on 2026-07-01
Listing for:
Katalyst CRO
Full Time
position Listed on 2026-07-01
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Katalyst CRO in Bothell, Washington is seeking a highly experienced professional to lead FDA audit and inspection readiness activities. This role requires 10 years of expertise in Quality, Compliance, or related fields within regulated environments such as Pharma or Biotechnology.
The ideal candidate will own CAPA effectiveness, prepare for FDA inspections, and mentor teams on compliance expectations. Strong leadership, regulatory knowledge, and excellent communication skills are essential for success in this position.
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