Michael Morad

Michael Morad Email and Phone Number

Vice President, Global Quality Systems and Compliance (Interim) @ Gilead Sciences
San Mateo, CA, US
Michael Morad's Location
San Francisco Bay Area, United States, United States
Michael Morad's Contact Details
About Michael Morad

Quality and regulatory executive leader with over 20 years of global experience in the diagnostics, medical devices, combination products and healthcare industries. A visionary and synergistic leader that catalyzes teams to overcome complexities and deliver amazing products that delight customers. In depth knowledge of quality operations, quality systems, regulatory compliance and clinical quality, including CLIA, GCP, GLP, GMP, 21CFR Parts 50, 54, 56, 58, 210, 211 and 820, ISO 27001, 27017, 27018, 9001, 13485, 14971 and 14155, IVDR, MDR and MDSAP.

Michael Morad's Current Company Details
Gilead Sciences

Gilead Sciences

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Vice President, Global Quality Systems and Compliance (Interim)
San Mateo, CA, US
Website:
gilead.com
Employees:
14647
Michael Morad Work Experience Details
  • Gilead Sciences
    Vice President, Global Quality Systems And Compliance (Interim)
    Gilead Sciences
    San Mateo, Ca, Us
  • Gilead Sciences
    Vice President (Interim), Global Pharmaceutical Quality Systems And Compliance
    Gilead Sciences Nov 2024 - Present
    Foster City, Ca, Us
  • Gilead Sciences
    Executive Director, Medical Device Combination Products Quality
    Gilead Sciences 2023 - Present
    Foster City, Ca, Us
    Head Quality function for Medical Devices and Combination Products
  • Combination Products Coalition
    Steering Committee Member
    Combination Products Coalition 2023 - Present
  • Thermo Fisher Scientific
    Head Of Quality, Clinical Sequencing Division
    Thermo Fisher Scientific 2022 - 2023
    Waltham, Ma, Us
  • Roche
    Sr. Director, Global Head Quality Operations
    Roche 2016 - 2022
    Switzerland 🇨🇭 , Ch
    Global Head of Quality Operations at multiple sites located in USA, Europe and South Africa. Member of IVDR and MDR Global Steering Committee for Quality and Regulatory which ensured Roche's readiness and right to operate under the new regulations for hundreds of products on the EU market. Led successful integrations of seven acquisitions to the Roche Sequencing Unit, including management of complex supply chain, operations and compliance matters that were the result of rapid year over year sales growth rates of 25-40%.
  • Cardinal Health
    Director, Global Regulatory Compliance & Clinical Quality, Asia Pacific Qa & Ra Leader
    Cardinal Health 2013 - 2016
    Dublin, Oh, Us
    Led formation and certification of 13 new sites in the EU and APAC regions within 18 months in order to meet company divestiture commitments. Led due diligence and supplier evaluations to support rapid business growth in the region.Hosted over 60 successful inspections with the USFDA, BSI and DEKRA as well as local authorities in Japan and Australia. Managed global GCP/GLP program for several clinical trials involving class II/III vascular products. Managed global recall/field action risk management program for the entire product portfolio.
  • Johnson & Johnson
    Senior Manager, Global Quality Compliance
    Johnson & Johnson 2013 - 2015
    New Brunswick, Nj, Us
    Managed global auditing and inspection readiness program for four manufacturing and corporate sites. Hosted over 40 successful inspections with the USFDA, DEKRA, BSI and CA FDB. Managed global GCP/GLP program for several clinical trials involving class II/III vascular products. Managed global recall/field action risk management program for the entire product portfolio.
  • Covidien (Medtronic Minimally Invasive Therapies Group)
    Plant Quality & Compliance Manager
    Covidien (Medtronic Minimally Invasive Therapies Group) 2012 - 2013
    Fridley, Minnesota, Us
    Hosted over eight successful inspections involving the USFDA, CA FDB, ANVISA and Japan authorities. Responsible for contract manufacturer evaluation and qualification for the transfer of three vascular therapy product lines to Costa Rica within six months. Responsible for all aspects of quality to support R&D, Clinical and Operations at the site.
  • Abbott
    Abbott Labs - Various Management Roles (Diagnostics & Vascular Divisions)
    Abbott 2005 - 2012
    Abbott Park, Illinois, Us
    Complaint Handling, R&D Quality, Software Quality, Operations Quality, Risk Management
  • Stanford Hospital
    Clinical Labs Supervisor
    Stanford Hospital 2003 - 2005
    Palo Alto, California, Us
    Clinical Lab Operations, CLIA, JACHO, CAP

Michael Morad Skills

Capa Quality Assurance Validation Medical Devices Fda Quality Auditing Quality Management Regulatory Affairs Quality Control Iso 13485 Gmp Project Management Clinical Research Complaint Management Supplier Quality Microbiology 21 Cfr Iso 9000 Supply Management Statistics Software Quality Assurance Complaints Management Complaints Handling 510k Phlebotomy Implants Sustainability Operations Field Training Physician Relations Irb Oem Relations Clinical Trails Research And Development Supplier Management Internal Audits External Audits Regulatory Compliance Vigilance Clinical Labs International Business Global Compliance Physician Training Training Development Iso 9001 21cfr Ivdd Lab Management Quality Engineering Trending Analysis

Michael Morad Education Details

  • Purdue University Daniels School Of Business
    Purdue University Daniels School Of Business
    Master Of Business Administration - Executive Mba
  • San José State University
    San José State University
    Medical Product Development Management
  • San José State University
    San José State University
    Molecular Biology

Frequently Asked Questions about Michael Morad

What company does Michael Morad work for?

Michael Morad works for Gilead Sciences

What is Michael Morad's role at the current company?

Michael Morad's current role is Vice President, Global Quality Systems and Compliance (Interim).

What is Michael Morad's email address?

Michael Morad's email address is mi****@****che.com

What schools did Michael Morad attend?

Michael Morad attended Purdue University Daniels School Of Business, San José State University, San José State University.

What are some of Michael Morad's interests?

Michael Morad has interest in Education.

What skills is Michael Morad known for?

Michael Morad has skills like Capa, Quality Assurance, Validation, Medical Devices, Fda, Quality Auditing, Quality Management, Regulatory Affairs, Quality Control, Iso 13485, Gmp, Project Management.

Who are Michael Morad's colleagues?

Michael Morad's colleagues are Winnie Young, Christian Aguila, Keli'i Unga, Susie Huang, Cherrilyn L., Alexandre Mercier, Shrada Chitlangia.

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