Sonam Patil
Senior Manager Quality Assurance @Mint Pharmaceuticals
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WORK HISTORY
Senior Manager Quality Assurance @Mint Pharmaceuticals
EDUCATION
Rutgers University
Executive Training in Pharmaceutical Management
Roosevelt University
Masters of Business Administration (MBA), International Business
University of Mumbai
Bachelor's degree, Pharmaceutical Sciences
ABOUT SONAM PATIL
Quality-focused senior leader with 10+ years of experience in Clinical Operations, Quality Assurance, and Regulatory Compliance across GCP, GMP, and GLP environments. Proven ability to drive strategic direction, oversee global quality compliance, and implement continuous improvement initiatives to enhance operational efficiency. Expert in risk-based quality management, CAPA investigations, vendor performance management, and Key Risk Indicators (KRIs) to proactively identify and mitigate compliance risks. Skilled in hosting and leading regulatory and client audits, managing recalls, and maintaining DEL and MDEL compliance, ensuring adherence to EMA, FDA, PMDA, and Health Canada regulations. Strong leadership in stakeholder collaboration, cross-functional coordination, and quality governance, ensuring alignment with Key Performance Indicators (KPIs) and KRIs for quality, compliance, and business excellence. Provides technical oversight for CMOs and key clients, driving regulatory adherence and operational success
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