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Alicia Sonne

@aliciasonne1

I am an experienced quality assurance leader in pharmaceutical and 3PL compliance.

United States
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What I'm looking for

I seek a leadership role owning QMS and regulatory compliance in pharma/medical device or 3PL environments, where I can lead audits, mentor teams, drive CAPA and continuous improvement in a collaborative, safety-focused culture.

I manage all aspects of quality management for large 3PL warehouses, overseeing operations that include cold chain, controlled substances, biologics, medical devices and animal health products for multiple active accounts.

I lead multidisciplinary investigations from root cause analysis through corrective/preventative action implementation and effectiveness verification, and I regularly host audits for clients, regulatory agencies and corporate auditors.

I am proficient with SmartSolve and Microsoft Office and well versed in ISO 9001, ISO 13485, 21 CFR compliance and 3PL licensing requirements; I also assisted with QMS implementation in a new million-square-foot warehouse.

I drive KPI trending and presentations, document control, training programs and inspection/release activities, and I build and develop quality teams focused on compliance, continuous improvement and operational excellence.

Experience

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Education

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