Karla Longo Gouveia

Associate Director Quality Assurance @Merck

York, PA, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Sep 2010 — Present

Associate Director Quality Assurance @Merck

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US

EDUCATION

N/A

Universidade Paulista

Postgraduate Degree, Clinical Pharmacology

N/A

Universidade Cruzeiro do Sul (UNICSUL)

Postgraduate Degree, Sports nutrition

N/A

Penn State University

Postgraduate Degree, Project Management

N/A

Universidade Paulista

Bachelor's degree, Pharmacy and Biochemistry

SKILLS

AuditingQuality ManagementManufacturingGampTechnology TransferSoftware DocumentationQuality AssuranceValidationManagementLimsIsoPharmaceutical IndustrySopFdaCleaning ValidationComputer System ValidationCapaQuality SystemV&VTrackwiseCross-Functional Team LeadershipRegulatory AffairsRegulatory SubmissionsPharmacovigilanceQuality ControlGmpGlpProject PlanningChange ControlGcp21 Cfr Part 11Six SigmaGxpQuality AuditingAseptic ProcessingPharmaceuticsRegulatory Requirements

ABOUT KARLA LONGO GOUVEIA

With over 25 years of global experience in pharmaceutical quality, I lead GMP compliance and quality systems initiatives that drive enterprise-level impact across clinical and commercial programs. I specialize in aligning regulatory frameworks, operational processes, and organizational strategy to ensure robust, compliant, and efficient quality outcomes.I have a proven track record in global quality system transformations, inspection readiness (FDA, EMA, ANVISA), and design control implementation. I focus on building high-performing teams, developing future talent, and fostering collaborative environments that deliver measurable results.A marathoner at heart, I bring dedication, perseverance, and focus to every challenge, whether leading cross-functional teams, optimizing processes through Lean principles, or driving strategic initiatives. My goal is to combine regulatory expertise, operational leadership, and people development to enable sustainable quality excellence and organizational growth.

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