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Jose Caraballo Oramas Email & Phone Number
Vice President Quality: Compliance, Quality Systems, and Quality Engineering
at
Kite Pharma
1 work email found
@bayer.com
2 phones found area 787 and 847
LinkedIn matched
✓ Verified May 2026
4 data sources
Profile completeness 100%
Current company
Role
Vice President Quality: Compliance, Quality Systems, and Quality Engineering
Location
Santa Monica, California, United States
Who is Jose Caraballo Oramas? Overview
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Quick answer
Jose Caraballo Oramas is listed as Vice President Quality: Compliance, Quality Systems, and Quality Engineering at Kite Pharma, based in Santa Monica, California, United States. AeroLeads shows a work email signal at bayer.com, phone signal with area code 787, 847, and a matched LinkedIn profile for Jose Caraballo Oramas.
Jose Caraballo Oramas previously worked as Co-Chair ISPE Guidance Document Committee (CDC) at Ispe and Vice President Quality: Compliance, Quality Systems, and Quality Engineering. QA LIMS at Kite Pharma. Jose Caraballo Oramas holds Executive Presence And Influence: Persuasive Leadership Development, Organizational Leadership from Wharton Executive Education.
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*@bayer.com
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Profile bio
About Jose Caraballo Oramas
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.
Listed skills include Validation, Quality System, Pharmaceutical Industry, Technology Transfer, and 46 others.
Current workplace
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21 roles
Jose Caraballo Oramas work experience
A career timeline built from the work history available for this profile.
Co-Chair Ispe Guidance Document Committee (Cdc)
Current- 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.
Dec 2024 - Present
Vice President Quality: Compliance, Quality Systems, And Quality Engineering. Qa Lims
Current- 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.
Sep 2024 - Present
Vice President Quality: Global Head Of Compliance, Quality Systems, And Quality Engineering
- 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.
Jun 2021 - Sep 2024
Board Member, Advanced Therapy Medicinal Products Advisory Board (Atmp Ab)
Current
Jun 2023 - Present
Member Of Editorial Board - Pda Journal Of Pharmaceutical Science And Technology
Current
Feb 2019 - Present
Board Member, Biotechnology Advisory Board (Bioab)
Jan 2020 - Oct 2023
Head Corporate Audit Program Management, Americas
Direct 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.
Jan 2020 - Jun 2021
Quality Lead Cell Culture Technology Center (Cctc) , Quality Product Steward
Drive 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.
Nov 2018 - Jan 2020
Quality Product Steward And Quality Lead
Quality 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.
May 2018 - Nov 2018
Quality Product Steward, Hematology
Accountable for global end-to-end product quality for hematology franchise products (Kovaltry and Jivi).
Jul 2016 - May 2018
Director, Global Quality Assurance, Biotech
Directed 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.
Jan 2013 - Jun 2016
Co-Lead For Ispe Guide: Cleaning Validation Lifecycle - Applications, Methods, And Controls
Aug 2017 - Aug 2020
Director Validation
Directed 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.
Jun 2009 - Jan 2013
Sr. Principal Engineer
Managed 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.
Oct 2007 - Jun 2009
Director Site Quality Assurance
As 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.
Feb 2004 - Oct 2007
Director/Manager, Quality Operations Biotech Expansion Team
Directed 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.
Aug 2002 - Feb 2004
Section Head, Fermentation Development
Directed 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.
Aug 2000 - Jul 2002
Qa Site Head
QA 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).
Jun 1995 - Aug 2000
Manufacturing Science And Technology (Msat) Section Manager
Responsible 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.
Jan 1989 - May 1995
Automation Section Head
Implemented 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..
Jun 1986 - Dec 1988
6 education records
Jose Caraballo Oramas education
Executive Presence And Influence: Persuasive Leadership Development, Organizational Leadership
Wharton Executive Education
Mba, Business Administration And Management, General
University Of Phoenix
M.E., Chemical Engineering
University Of Puerto Rico-Mayaguez
Fermentation Technology
Massachusetts Institute Of Technology
B.S., Chemical Engineering
University Of Puerto Rico-Mayaguez
Education record
Centro Residencial De Oportunidades Educativas De Mayagüez (Croem)
FAQ
Frequently asked questions about Jose Caraballo Oramas
Quick answers generated from the profile data available on this page.
What company does Jose Caraballo Oramas work for?
Jose Caraballo Oramas works for Kite Pharma.
What is Jose Caraballo Oramas's role at Kite Pharma?
Jose Caraballo Oramas is listed as Vice President Quality: Compliance, Quality Systems, and Quality Engineering at Kite Pharma.
What is Jose Caraballo Oramas's email address?
AeroLeads has found 1 work email signal at @bayer.com for Jose Caraballo Oramas at Kite Pharma.
What is Jose Caraballo Oramas's phone number?
AeroLeads has found 2 phone signal(s) with area code 787, 847 for Jose Caraballo Oramas at Kite Pharma.
Where is Jose Caraballo Oramas based?
Jose Caraballo Oramas is based in Santa Monica, California, United States while working with Kite Pharma.
What companies has Jose Caraballo Oramas worked for?
Jose Caraballo Oramas has worked for Kite Pharma, Ispe, Pda - Parenteral Drug Association, Bayer, and Amgen.
How can I contact Jose Caraballo Oramas?
You can use AeroLeads to view verified contact signals for Jose Caraballo Oramas at Kite Pharma, including work email, phone, and LinkedIn data when available.
What schools did Jose Caraballo Oramas attend?
Jose Caraballo Oramas holds Executive Presence And Influence: Persuasive Leadership Development, Organizational Leadership from Wharton Executive Education.
What skills is Jose Caraballo Oramas known for?
Jose Caraballo Oramas is listed with skills including Validation, Quality System, Pharmaceutical Industry, Technology Transfer, Gmp, V&V, Biotechnology, and Quality Assurance.
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