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Vast experience in development and implementation of all Quality Systems and EHS globallyQuality System Remediation experienceRobust Quality Management experienceAnalytics and Insights experience including AI and ML Quality Commercial responsibility for APAC/EMEA/LatAm and CanadaFull understanding of manufacturing, technical services and supply chain processes in the Pharmaceutical Industry environmentMedical Devices and Nutritional products experienceStrong knowledge of FDA and Global Regulatory Agencies requirementsStrong business understandingVisionary leaderLEAN manufacturing experienceSuccessfully lead two organization into the completion of FDA Consent Decree obligationsLatin American Sites experienceFully bilingual ( Spanish and English)Specialties: Vast knowledge in Pharmaceutical Manufacturing processes including solid dosages,liquids, parenterals and ointments.Strong Quality experience and Global Regulatory knowledge
Abbott Laboratories
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Dvp Global Compliance And Quality OperationsAbbott Laboratories May 2014 - PresentResponsible for Corporate Global Compliance, Quality Systems Operations, Global Environmental Health and Safety including Global Commercial EHS, Global Product Stewardship, Global Quality Analytics including Predictive Analytics and AI and Corporate Knowledge Management
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Vp Global Quality Commercial And Quality AuditsHospira Jan 2014 - May 2014Lake Forest, Il, UsResponsible for Global Quality Commercial Functions- EMEA, APAC, LatAm, USA and CanadaResponsible for Global Third Party Manufacturing ( TPM ) and Global Quality Distribution functionsResponsible for Global Quality Audits- Corporate/TPM/SuppliersResponsible for Inspection Readiness -
Vice President Compliance And Quality SystemsHospira May 2012 - May 2014Lake Forest, Il, UsResponsible for definition and implementation of Global Quality Systems for Pharmaceutical and Medical Devices OperationsResponsible for Quality function at Int'l Commercial Regions- APAC/LatAm and CanadaResponsible for Corporate Internal Audit and Inspection Excellence functions -
Sr.Director QualityAstrazeneca Pharmaceuticals Jul 2006 - May 2012Cambridge, Cambridgeshire, Gb -
Director Global Quality OperationsSchering-Plough Pharmaceuticals Feb 2001 - Jun 2006Rahway, New Jersey, UsResponsible for all Quality functions including, Laboratories, QA, Regulatory and Quality Systems -
Qa And Regulatory DirectorWarner Lambert 1992 - 1999Us -
Qa ManagerWyeth 1985 - 1992New York, New York, Us -
Qa SupervisorLederle Parenteral, Carolina , Pr 1985 - 1992
Agnes Ortega Skills
Agnes Ortega Education Details
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University Of Puerto RicoBiology -
Colegio Lourdes
Frequently Asked Questions about Agnes Ortega
What company does Agnes Ortega work for?
Agnes Ortega works for Abbott Laboratories
What is Agnes Ortega's role at the current company?
Agnes Ortega's current role is Divisional Vice President Corporate Global Compliance and Global Quality Operations at Abbott.
What is Agnes Ortega's email address?
Agnes Ortega's email address is ag****@****hoo.com
What is Agnes Ortega's direct phone number?
Agnes Ortega's direct phone number is +197052*****
What schools did Agnes Ortega attend?
Agnes Ortega attended University Of Puerto Rico, Colegio Lourdes.
What skills is Agnes Ortega known for?
Agnes Ortega has skills like Fda, Quality System, Pharmaceutical Industry, Quality Assurance, Gmp, Capa, Quality Management, Validation, Change Control, Medical Devices, Lean Manufacturing, 21 Cfr Part 11.
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