Morayma Cotto
Business Director Latam @Quascenta
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WORK HISTORY
Business Director Latam @Quascenta
PR
EDUCATION
Universidad del Turabo
Mechanical Engineering
SKILLS
ABOUT MORAYMA COTTO
Strategic Validation and Compliance Project Manager with 26+ years of progressive leadership in the pharmaceutical, biotechnology, biologics, medical device, and chemical sectors. Extensive expertise in FDA/EMA regulatory compliance, cGMP environments, and FDA Consent Decree remediation. Proven track record of leading multimillion-dollar validation programs, establishing robust quality systems, and managing technology transfers, process/equipment/cleaning validation, and regulatory audits. Adept at cross-functional team leadership and aligning validation strategy with business and compliance objectives.CORE COMPETENCIES:FDA, EMA, ICH, cGMP, ISO 13485 ComplianceValidation Lifecycle (VMP, URS, DQ, IQ, OQ, PQ, PPQ)Computer System Validation (CSV), 21 CFR Part 11Equipment, Process, Cleaning, and Utility ValidationConsent Decree & Regulatory Remediation ProjectsRisk Management & CAPA SystemsTechnology Transfers & New Facility CommissioningAudit Readiness (FDA, EMA, Notified Bodies)Change Control, Deviation ManagementCross-functional Team Leadership & TrainingVeeva, COMET,Trackwise, WIndchill,PQMS
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