Monica Mount

Head of Us Quality @CSL Vifor

Annapolis, MD, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2022 — Present

Head of Us Quality @CSL Vifor

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King of Prussia, PA, US

As the Head of US Quality, I am responsible for the Quality Management System. This includes setting quality goals, continuous improvement and a highly effective collaboration with Senior Leadership including Commercial, Medical Affairs, Market Access, Trade and Distribution, Regulatory Affairs, Pharmacovigilance, and IT. Our highly effective QMS includes robust processes that encompass: CAPA and Deviation Management, Vendor Management, Management Reviews, Change Management, Complaint Management, Internal and External auditing, training and streamlined procedures.

EDUCATION

N/A

Rutgers University, College of Engineering

Bachelor of Science (B.S.)

SKILLS

U.s. Food and Drug Administration (Fda)Project ManagementStrategyMedical DevicesQuality AuditingRegulatory AffairsStandard Operating Procedure (Sop)Pharmaceutical IndustryBusiness Process ImprovementFdaValidationChange ControlChange ManagementQuality System ComplianceProcess ImprovementCross-Functional Team LeadershipQuality AssuranceBusiness ProcessGmp

ABOUT MONICA MOUNT

Experienced Quality professional with a demonstrated history of working in the…

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