Rubén J. Plaza M.B.A

Rubén J. Plaza M.B.A Email and Phone Number

Associate Director, CSV at Gossamer Bio @ Gossamer Bio
Rubén J. Plaza M.B.A's Location
Los Angeles, California, United States, United States
Rubén J. Plaza M.B.A's Contact Details

Rubén J. Plaza M.B.A personal email

About Rubén J. Plaza M.B.A

Rubén J. Plaza M.B.A is a Associate Director, CSV at Gossamer Bio at Gossamer Bio. He possess expertise in computer system validation, validation, integration, gmp, 21 cfr part 11 and 14 more skills. Colleagues describe him as "Ruben is an excellent business systems analyst and came to rescue a laboratory inventory system that required several upgrades to remain the useful tool it once was! I greatly appreciated his understanding of the need, the help in convincing the organization of the need, and his help in taking the action required to plan the path forward."

Rubén J. Plaza M.B.A's Current Company Details
Gossamer Bio

Gossamer Bio

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Associate Director, CSV at Gossamer Bio
Rubén J. Plaza M.B.A Work Experience Details
  • Gossamer Bio
    Associate Director, Csv
    Gossamer Bio May 2023 - Present
    San Diego, California, Us
  • Instil Bio
    Qe Director
    Instil Bio Mar 2021 - Present
    Implemented and managed corporate programs for Computer Systems Validation CSV, Facilities, Equipment, Utilities, Instruments (CQV), Data Integrity and Risk Management, to enable quality and performance by design, ad a means to accomplish a sustainable and scalable production model.
  • Kite Pharma, Inc.
    Sr. Manager Quality Engineering & Computer Systems
    Kite Pharma, Inc. Mar 2017 - Mar 2021
    Santa Monica, California, Us
    Established and managed all aspects of the validation program for local and enterprise computerized systems including systems assessment, creation, execution validation, implementation of procedures, policies, change control management, vendor assessment, training, coordination and partnership with cross functional departments at Kite and outsourced consultants.
  • Tata Consultancy Services
    Manager Csv
    Tata Consultancy Services Sep 2014 - Mar 2017
    Mumbai, Maharashtra, In
    Serve as a subject matter expert in the area of computer systems validation (CSV) & quality systems implementation in the regulatory industry of medical devices and pharmaceutical manufacturing.
  • Bd
    Global Business Systems Analyst
    Bd Oct 2011 - Sep 2014
    Franklin Lakes, New Jersey, Us
    Supported R&D department globally as part of the corporate IT department. Implemented Product Lifecycle Management system (Material Master/Design Spec, Bill of Material) in SAP, including Change Control and Document Management modules.
  • Boehringer Ingelheim
    Principal Systems Analyst
    Boehringer Ingelheim Jun 2009 - Oct 2011
    Ingelheim Am Rhein, Rhineland-Palatinate, De
    Developed and supported global and local computerized analytical systems utilized in QC and R&D laboratories. Identified areas of improvements, developed business cases to address gaps in collaboration with corporate IT and presented/influenced local management on technology solutions to improve operations (automation, data management, regulatory compliance and audit readiness)
  • Clarkston Consulting
    Functional Consultant
    Clarkston Consulting 2005 - 2009
    Durham, Nc, Us
    Implemented quality systems and enterprise resource planning (ERPs) throughout complete system development life cycle in accordance with FDA regulations. Assisted business development efforts by serving as a subject matter expert at life science conferences and pursued leads for potential business opportunities.
  • Pharmabioserv
    Computer Systems Validation And Automation Specialist
    Pharmabioserv 2002 - 2005
    Assessed and commissioned/validated multiple technologies, computer systems and equipment supporting quality operations of pharmaceutical drug manufacturing.
  • Nasa - (Johnson Engineering), Autopak Engineering, Kinetics Fluid Systems (Applied Materials)
    Computer Aided Designer
    Nasa - (Johnson Engineering), Autopak Engineering, Kinetics Fluid Systems (Applied Materials) Dec 1993 - Sep 2002
    Designed automated mechanical systems for the Aeronautical, Pharmaceutical and semiconductor industries. Created designs in Computer Aided Design systems such as AutoCad and Pro-Engineering. Participated in the development, design, construction and installation of automated-integrated systems with cross-functional teams within companies and external clients.

Rubén J. Plaza M.B.A Skills

Computer System Validation Validation Integration Gmp 21 Cfr Part 11 Pharmaceutical Industry Change Control Fda Quality System Management Cross Functional Team Leadership R&d Leadership U.s. Food And Drug Administration Business Process Improvement Quality Assurance Enterprise Resource Planning Medical Devices Business Analysis

Rubén J. Plaza M.B.A Education Details

  • Purdue University Fort Wayne
    Purdue University Fort Wayne
    Master Of Business Administration (M.B.A.)
  • St.Edward'S University
    St.Edward'S University
    General
  • The Art Institute Ofhouston
    The Art Institute Ofhouston
    Computer Aided Drafting And Design

Frequently Asked Questions about Rubén J. Plaza M.B.A

What company does Rubén J. Plaza M.B.A work for?

Rubén J. Plaza M.B.A works for Gossamer Bio

What is Rubén J. Plaza M.B.A's role at the current company?

Rubén J. Plaza M.B.A's current role is Associate Director, CSV at Gossamer Bio.

What is Rubén J. Plaza M.B.A's email address?

Rubén J. Plaza M.B.A's email address is pl****@****hoo.com

What schools did Rubén J. Plaza M.B.A attend?

Rubén J. Plaza M.B.A attended Purdue University Fort Wayne, St.edward's University, The Art Institute Ofhouston.

What skills is Rubén J. Plaza M.B.A known for?

Rubén J. Plaza M.B.A has skills like Computer System Validation, Validation, Integration, Gmp, 21 Cfr Part 11, Pharmaceutical Industry, Change Control, Fda, Quality System, Management, Cross Functional Team Leadership, R&d.

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