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Wilfredo Ortiz

Vice President and Site Head @Glenmark Pharmaceuticals

Monroe, NC, US
EMAILS
w••••••••@glenmarkpharma.com
MOBILE NUMBERS
+16•••••••54

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WORK HISTORY

Jul 2021 — Present

Vice President and Site Head @Glenmark Pharmaceuticals

Monroe, NC, US

Head of Monroe NC manufacturing site for Glenmark Pharmaceuticals.

EDUCATION

N/A

University of Puerto Rico-Mayaguez

B.S., Mechanical Engineering

N/A

Baylor University - Hankamer School of Business

MBA, Bussiness Management

SKILLS

Standard Operating Procedure (Sop)Product DevelopmentTechnology TransferPreventive MaintenanceCgmp ManufacturingProcess ImprovementCross-Functional Team LeadershipPackagingGmpBiopharmaceuticalsPharmaceutical IndustryBusiness Process ImprovementSopMaintenance ManagementFdaContinuous ImprovementCorrective and Preventive Action (Capa)Medical DevicesCapaU.s. Title 21 Cfr Part 11 RegulationClean RoomsValidation21 Cfr Part 11Bulk Heat SterilizationKfdaFilter SterilizationQuality SystemV&VWorkflowSterilizationRegulatory AffairsManufacturing Operations ManagementAseptic TechniqueAseptic ProcessingProject ManagementU.s. Food and Drug Administration (Fda)Plant LayoutRabVerification and Validation (V&V)Lean Manufacturing

ABOUT WILFREDO ORTIZ

I am a seasoned pharmaceutical executive with over 25 years of experience in operations management, process improvement, quality management systems, and regulatory compliance. As the Vice President and Site Head at Glenmark Pharmaceuticals, a global leader in developing and producing innovative medicines, I oversee the Monroe, NC, manufacturing site that produces aseptically filled pharmaceutical products for various therapeutic areas.My passion is creating dynamic learning environments where people are empowered to excel and deliver. I have successfully led multiple projects and teams designing, constructing, installing, and qualifying equipment and processes for sterile and topical manufacturing and packaging facilities. I also have extensive experience handling GMP inspections by FDA and international agencies, ensuring the highest standards of quality and safety. I aim to leverage my MBA degree and process improvement expertise to drive innovation, efficiency, and growth for Glenmark Pharmaceuticals and the industry.

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