Agnes Ortega

Agnes Ortega Email and Phone Number

Divisional Vice President Corporate Global Compliance and Global Quality Operations at Abbott @
Agnes Ortega's Location
Greater Chicago Area, United States, United States
Agnes Ortega's Contact Details
About Agnes Ortega

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

Agnes Ortega's Current Company Details
Abbott Laboratories

Abbott Laboratories

Divisional Vice President Corporate Global Compliance and Global Quality Operations at Abbott
Agnes Ortega Work Experience Details
  • Abbott Laboratories
    Dvp Global Compliance And Quality Operations
    Abbott Laboratories May 2014 - Present
    Responsible 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
  • Hospira
    Vp Global Quality Commercial And Quality Audits
    Hospira Jan 2014 - May 2014
    Lake Forest, Il, Us
    Responsible 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
  • Hospira
    Vice President Compliance And Quality Systems
    Hospira May 2012 - May 2014
    Lake Forest, Il, Us
    Responsible 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
  • Astrazeneca Pharmaceuticals
    Sr.Director Quality
    Astrazeneca Pharmaceuticals Jul 2006 - May 2012
    Cambridge, Cambridgeshire, Gb
  • Schering-Plough Pharmaceuticals
    Director Global Quality Operations
    Schering-Plough Pharmaceuticals Feb 2001 - Jun 2006
    Rahway, New Jersey, Us
    Responsible for all Quality functions including, Laboratories, QA, Regulatory and Quality Systems
  • Warner Lambert
    Qa And Regulatory Director
    Warner Lambert 1992 - 1999
    Us
  • Wyeth
    Qa Manager
    Wyeth 1985 - 1992
    New York, New York, Us
  • Lederle Parenteral, Carolina , Pr
    Qa Supervisor
    Lederle Parenteral, Carolina , Pr 1985 - 1992

Agnes Ortega Skills

Fda Quality System Pharmaceutical Industry Quality Assurance Gmp Capa Quality Management Validation Change Control Medical Devices Lean Manufacturing 21 Cfr Part 11 Regulatory Affairs Quality Control Cross Functional Team Leadership Technology Transfer Manufacturing Leadership Pharmaceutics Sop V&v Aseptic Processing Glp Change Management Computer System Validation Six Sigma Process Improvement Regulatory Submissions Cleaning Validation Multilingual Root Cause Analysis Solid Oral Dosage Forms Trackwise Continuous Improvement Supply Chain Supply Chain Management Injectable R&d Strong Gmp Knowledge Pharmaceutical Manufacturing Process Engineering Operational Excellence Fully Bilingual Solid Dosage And Injectables Value Stream Mapping 5s Dmaic Iso Process Simulation Supply Management

Agnes Ortega Education Details

  • University Of Puerto Rico
    University Of Puerto Rico
    Biology
  • Colegio Lourdes
    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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