Sr Quality Compliance Associate

Danaher Corporation Office Usa

Senior Quality Compliance Associate at Aldevron (Danaher) leads complex quality system activities, provides advanced oversight, and drives continuous improvement across the Fargo site. The role serves as subject matter expert partnering across functions to assess risks, resolve compliance issues, and strengthen regulatory readiness.

Responsibilities

Review and approve complex deviations, CAPAs, change controls, and quality system records for regulatory compliance
Mentor and train quality system owners while serving as subject matter expert for requirements and best practices
Analyze quality metrics, identify adverse trends, and escalate significant compliance risks
Lead continuous improvement initiatives enhancing system effectiveness and inspection readiness
Partner with operational and regulatory stakeholders on audits, inspections, and strategic projects

Requirements

Bachelor's degree in biology, microbiology, chemistry, or related life science field
4+ years Quality Assurance experience in regulated pharmaceutical, biotech, or medical device industry
Advanced experience managing and reviewing deviations, CAPAs, and change controls
Experience leading cross-functional investigations and compliance initiatives
Demonstrated ability analyzing quality metrics and driving continuous improvement
ASQ or RAPS certification preferred
Biologics or cell and gene therapy experience preferred

Apply

Vacancy posted 2 days ago

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