Jose Caraballo Oramas Email and Phone Number
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As a results-driven leader in biotechnology, pharmaceuticals, and cell and gene therapies, I combine deep scientific expertise with strategic business insight to drive innovation and excellence. My career spans the full product lifecycle—from development and MSAT to quality systems and global commercialization—underpinned by a strong commitment to delivering transformative therapies to patients worldwide.With extensive experience leading global quality operations, I have successfully implemented scalable, compliant systems that meet the evolving demands of a fast-paced industry. My track record includes the design and execution of global quality systems, leading over 100 compliance audits, and navigating more than 40 successful regulatory inspections across multiple markets. These efforts have consistently resulted in measurable improvements in compliance, operational efficiency, and product readiness.Currently, as Vice President of Quality at Kite, I am overseeing digital transformation initiatives, including Digital Validation and a Global Quality LIMS program. These projects are modernizing traditional paper-based systems into agile, data-driven solutions, significantly advancing organizational efficiency and digital maturity.I thrive at the nexus of technology, systems, and operations, leading high-performing global teams to deliver operational excellence. My leadership has driven capacity expansions, accelerated start-ups, and facilitated successful product launches, creating lasting value for organizations and patients alike.An advocate for industry advancement, I actively contribute to thought leadership through organizations like PDA and ISPE. As a holder of ASQ certifications in Quality Engineering, Auditing, and Quality Management/Organizational Excellence, I remain committed to fostering a culture of innovation and quality in all my endeavors.
Kite Pharma
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Vice President Quality: Compliance, Quality Systems, And Quality EngineeringKite PharmaSanta Monica, Ca, Us
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Co-Chair Ispe Guidance Document Committee (Cdc)Ispe Dec 2024 - PresentNorth Bethesda, Maryland, Us• Collaborate with industry experts to provide timely feedback on ISPE Guidance Document proposals.• Contribute to the development of globally relevant, high-quality guidance for the pharmaceutical industry.• Support ISPE in identifying and addressing knowledge gaps within the industry.• Engage in strategic discussions to enhance the value delivery of the Global Documents Committee. -
Vice President Quality: Compliance, Quality Systems, And Quality Engineering. Qa LimsKite Pharma Sep 2024 - PresentSanta Monica, California, Us• Quality Assurance Lead for the advancement of Global Quality Laboratory Information Management System (LIMS) programs.• Implement paperless systems to enhance quality control operations and increase efficiencies.• Spearhead compliance, quality systems, and quality engineering initiatives to drive digital maturity.
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Vice President Quality: Global Head Of Compliance, Quality Systems, And Quality EngineeringKite Pharma Jun 2021 - Sep 2024Santa Monica, California, Us• Led corporate global compliance, quality systems, supplier quality management, and quality engineering functions for Kite Pharma.• Implemented advancements in quality system maturity for cell and gene therapies, deployed QMS, ERP, and digital validation systems.• Achieved excellent regulatory inspection performance and ensured compliance with industry standards.
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Board Member, Advanced Therapy Medicinal Products Advisory Board (Atmp Ab)Pda - Parenteral Drug Association Jun 2023 - PresentBethesda, Maryland, Us -
Member Of Editorial Board - Pda Journal Of Pharmaceutical Science And TechnologyPda - Parenteral Drug Association Feb 2019 - PresentBethesda, Maryland, Us
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Board Member, Biotechnology Advisory Board (Bioab)Pda - Parenteral Drug Association Jan 2020 - Oct 2023Bethesda, Maryland, Us
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Head Corporate Audit Program Management, AmericasBayer Jan 2020 - Jun 2021Leverkusen, North Rhine-Westphalia, DeDirect risk based auditing programs (resource planning, compliance, scheduling, execution, management) for North America, Central America, and Latin America as part of Corporate Quality Audits and Inspections. -
Quality Lead Cell Culture Technology Center (Cctc) , Quality Product StewardBayer Nov 2018 - Jan 2020Leverkusen, North Rhine-Westphalia, DeDrive quality efforts through design and construction phases for a groundbreaking single-use technology manufacturing facility housing cell and gene therapies and monoclonal antibodies that enable clinical/launch therapeutic protein production. Lead the quality strategy and systems (QMS) implementation for the Cell Culture Technology Center (CCTC). Direct end-to-end product quality objectives for monoclonal antibody (mAb) and continuous manufacturing platforms.
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Quality Product Steward And Quality LeadBayer May 2018 - Nov 2018Leverkusen, North Rhine-Westphalia, DeQuality Product Director for mAb platforms, Cell Culture Continuous Manufacturing, and Capacity Expansion Programs. Quality Lead for pre-launch biologics and projects using single use technologies.
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Quality Product Steward, HematologyBayer Jul 2016 - May 2018Leverkusen, North Rhine-Westphalia, DeAccountable for global end-to-end product quality for hematology franchise products (Kovaltry and Jivi).
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Director, Global Quality Assurance, BiotechBayer Jan 2013 - Jun 2016Leverkusen, North Rhine-Westphalia, DeDirected strategic planning and implementation support for new and existing operations for Biotech products (intermediates, drug substances and finished drug products). These include intra and inter-company process transfers, facility design reviews, validation methodology and strategy, quality system alignment and oversight, and launch of next generation products. Quality expert on strategic project teams related to the expansion of Biotech products manufacturing and testing capabilities.
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Co-Lead For Ispe Guide: Cleaning Validation Lifecycle - Applications, Methods, And ControlsIspe Aug 2017 - Aug 2020North Bethesda, Maryland, Us
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Director ValidationAmgen Jun 2009 - Jan 2013Thousand Oaks, Ca, UsDirected all aspects of validation (Strategy,Resources, Execution,Compliance) for a multi-plant biotechnology and pharmaceutical operations site. Main functions included staffing, project planning and execution, creation of compliance strategies, technology transfer support, technical support, and execution of validation studies for drug-substances and drug product biologics, combination products, and pharmaceutical solid dosage forms. Main areas of support included Equipment Qualifications, Risk Assessments, Computer/Cleaning/Process Validation, Sterility Assurance, Regulatory CMC Filings, Regulatory Inspections, Facilities Design Reviews, Facilities Start-ups, Environmental Monitoring Characterization Studies, and Strategic Validation Plans for New Product Introductions. -
Sr. Principal EngineerAmgen Oct 2007 - Jun 2009Thousand Oaks, Ca, UsManaged successful site productivity-related quality initiatives supporting operational excellence programs. Provided technical support and strategic direction to several initiatives including implementation of ERP and MES systems, Electronic Batch Records, and Product Serialization Programs.
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Director Site Quality AssuranceAmgen Feb 2004 - Oct 2007Thousand Oaks, Ca, UsAs QA Director for a multi-plant site, I led the Supplier Quality Management function, Documentation Services, Incoming Quality Assurance, Quality Control QA, Facilities QA, and Quality Systems Program. In earlier role as QA Director for Parenteral Operations, I directed the Quality Unit operations for Amgen's fill and finish facility (parenteral drug products, aseptic processing, isolator technologies). Responsibilities included the management of Quality Plant Operations, Product Disposition, Complaints Program, Supplier Quality Management, Quality Control QA, Quality Systems, Documentation Services, and Incomming Quality Assurance.
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Director/Manager, Quality Operations Biotech Expansion TeamAbbott Laboratories Aug 2002 - Feb 2004Abbott Park, Illinois, UsDirected the Quality Assurance planning, coordination, strategy, implementation, and support for the expansion of manufacturing capabilities, technology transfer, and validation for Adalimumab. Member of the Biotech Expansion Team responsible for multiple projects related to the expansion of biotechnology manufacturing capabilities. -
Section Head, Fermentation DevelopmentAbbott Laboratories Aug 2000 - Jul 2002Abbott Park, Illinois, UsDirected process improvements, product development, process scale-up, process validation, and general technical support for several fermentation based commercial products. Provided project management support for contract manufacturing and custom product programs.
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Qa Site HeadAbbott Laboratories Jun 1995 - Aug 2000Abbott Park, Illinois, UsQA Site Head responsible for all aspects of Quality Assurance Operations for a fermentation and purification drug substance plant (Plant QA, Regulatory Compliance, Incomming QA, Quality Control Laboratories, Quality Engineering, Supplier Quality Assurance, Quality Systems, Validation Program, Lot Disposition, Documentation Services, Product Complaints).
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Manufacturing Science And Technology (Msat) Section ManagerAbbott Laboratories Jan 1989 - May 1995Abbott Park, Illinois, UsResponsible for product recovery yields, process investigations, technical process engineering support, cost reduction programs, capital project justification, computer process control, process validations, and implementation of new technology and processes for downstream purification operations for a fermentation based drug substance plant.
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Automation Section HeadAbbott Laboratories Jun 1986 - Dec 1988Abbott Park, Illinois, UsImplemented automated control systems for world’s largest Erythromycin fermentation plant. Responsible for the design, documentation, installation, validation, personnel training and startup of a $1.6 million distributed process control computer and database host mainframe to digitally automate a previously fully manual antibiotic production process. Performed hardware qualification, computer validation, software configuration development, and production control software implementation.
Jose Caraballo Oramas Skills
Jose Caraballo Oramas Education Details
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Wharton Executive EducationOrganizational Leadership -
University Of PhoenixGeneral
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University Of Puerto Rico-MayaguezChemical Engineering
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Massachusetts Institute Of TechnologyFermentation Technology
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University Of Puerto Rico-MayaguezChemical Engineering
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Centro Residencial De Oportunidades Educativas De Mayagüez (Croem)
Frequently Asked Questions about Jose Caraballo Oramas
What company does Jose Caraballo Oramas work for?
Jose Caraballo Oramas works for Kite Pharma
What is Jose Caraballo Oramas's role at the current company?
Jose Caraballo Oramas's current role is Vice President Quality: Compliance, Quality Systems, and Quality Engineering.
What is Jose Caraballo Oramas's email address?
Jose Caraballo Oramas's email address is jo****@****hoo.com
What is Jose Caraballo Oramas's direct phone number?
Jose Caraballo Oramas's direct phone number is +178779*****
What schools did Jose Caraballo Oramas attend?
Jose Caraballo Oramas attended Wharton Executive Education, University Of Phoenix, University Of Puerto Rico-Mayaguez, Massachusetts Institute Of Technology, University Of Puerto Rico-Mayaguez, Centro Residencial De Oportunidades Educativas De Mayagüez (Croem).
What skills is Jose Caraballo Oramas known for?
Jose Caraballo Oramas has skills like Validation, Quality System, Pharmaceutical Industry, Technology Transfer, Gmp, V&v, Biotechnology, Quality Assurance, Fda, Capa, Aseptic Processing, Process Simulation.
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