Open to opportunities

Alicia Sonne

@aliciasonne1

Message

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

United States

Message

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

Work history, roles, and key accomplishments

Quality Assurance Supervisor

Arvato Bertelsmann

Mar 2018 - Nov 2018 (8 months)

Managed the Quality Management System for a 3PL warehouse with 5 active accounts distributing electronics, gaming systems, and cell phones. Updated SOPs, hosted management reviews and led the ISO 9001 recertification audit resulting in only 2 minor findings and implemented effective corrective actions.

Quality Management Systems ISO 9001 Root Cause Analysis CAPA Document Control Team Leadership Audit