Charles Mallory

Charles Mallory Email and Phone Number

Chief Quality Officer @ FibroGen, Inc.
New York, NY, US
Charles Mallory's Location
New York City Metropolitan Area, United States, United States
Charles Mallory's Contact Details

Charles Mallory personal email

n/a
About Charles Mallory

Pharmaceutical Quality executive with over 30 years of proven global leadership experience in the fields of Governance, Risk Management, Operational Excellence, Product Lifecycle Management, Data Integrity, Quality Operations, Clinical Quality Assurance, Quality Systems, Health Authority Inspections, Manufacturing, Supply Chain Operations, Vendor Management, Project Management and Strategic Planning.Mentored over a two-year period by Eugene Pfeifer, former lead litigator with FDA’s Office of Chief Counsel.Exceptional record of global Health Authority inspection success over the past 3 decades as the accountable Inspection Lead/Head of Quality.Extensive hands-on expertise in the operational application of the International Standards (ISO) for Governance, Risk Management, and Quality Management Systems.Operational experience with multiple dosage forms including oral solid, liquid, suspension, metered dose, transdermal, biologic, and combination drug/device.

Charles Mallory's Current Company Details
FibroGen, Inc.

Fibrogen, Inc.

View
Chief Quality Officer
New York, NY, US
Website:
fibrogen.com
Employees:
300
Charles Mallory Work Experience Details
  • Fibrogen, Inc.
    Chief Quality Officer
    Fibrogen, Inc.
    New York, Ny, Us
    View
  • Self-Employed
    Independent Quality & Data Governance Consultant
    Self-Employed Nov 2024 - Present
  • Fibrogen, Inc.
    Senior Vice President Of Quality
    Fibrogen, Inc. Jul 2020 - Oct 2024
    San Francisco, Ca, Us
    Responsible for the Quality oversight of global GxP operations (GLP, GMP, GCP and GVP).
    View
  • Bristol Myers Squibb
    Head, Quality Management System (Qms) Governance
    Bristol Myers Squibb Mar 2019 - Apr 2020
    Lawrence Township, Nj, Us
    Responsible for the governance of the company’s new global Clinical QMS.
    View
  • Endo Pharmaceuticals
    Vice President, Quality Operations - Branded Pharmaceuticals
    Endo Pharmaceuticals 2014 - 2018
    Malvern, Pa, Us
    Responsible for the Quality oversight of the company’s branded portfolio of 20+ products.
    View
  • Pf Laboratories
    Head Of Manufacturing/Research Qa
    Pf Laboratories 2004 - 2014
    Responsible for the QA oversight of R&D’s Non-Clinical, Product Development, Analytical Development, and Clinical Manufacturing/Packaging operations.
  • Teva Pharmaceuticals Usa, Inc. (Formerly Alpharma)
    Senior Director, Quality Systems
    Teva Pharmaceuticals Usa, Inc. (Formerly Alpharma) 2002 - 2004
    Nominated by expert outside legal counsel (two former attorneys from FDA’s Office of Chief Counsel) and selected by the CEO to develop and lead the remediation of the company’s commercial manufacturing Quality Management System in Baltimore, MD.
  • Baxter International Inc.
    Head, Quality Management System Improvement
    Baxter International Inc. 2000 - 2002
    Deerfield, Illinois, Us
    Retained by the executive Head of Quality for Baxter BioScience to develop and lead the QMS Remediation Plan for the company’s blood plasma fractionation facility in preparation for a critical re-inspection by FDA.
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  • Schering Pharmaceuticals
    Manufacturing & Supply Chain Leadership Roles
    Schering Pharmaceuticals 1990 - 2000
    Kenilworth, Nj, Us
    Plant Manager, Head of Strategic Operations Planning, Head of Supply Chain Operations, Head of Manufacturing Operations, Head of Distribution Operations, District Sales Manager, Head of Manufacturing QA, and Production Supervisor.
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  • U.S. Army
    Captain, United States Army
    U.S. Army May 1985 - Sep 1990
  • U.S. Army
    U.S. Army Ranger School
    U.S. Army Nov 1985 - Jan 1986
    Graduate of Class 2-86
  • U.S. Army
    U.S. Army Infantry Officer Basic Course
    U.S. Army Jun 1985 - Oct 1985

Charles Mallory Skills

Quality System Quality Assurance Fda Capa Gmp Pharmaceutical Industry Validation Regulatory Affairs Cross Functional Team Leadership Technology Transfer Medical Devices Biotechnology Gxp Good Laboratory Practice Change Control Manufacturing

Charles Mallory Education Details

  • United States Military Academy At West Point
    United States Military Academy At West Point
    Management (Operations)

Frequently Asked Questions about Charles Mallory

What company does Charles Mallory work for?

Charles Mallory works for Fibrogen, Inc.

What is Charles Mallory's role at the current company?

Charles Mallory's current role is Chief Quality Officer.

What is Charles Mallory's email address?

Charles Mallory's email address is ch****@****rma.com

What is Charles Mallory's direct phone number?

Charles Mallory's direct phone number is +148421*****

What schools did Charles Mallory attend?

Charles Mallory attended United States Military Academy At West Point.

What skills is Charles Mallory known for?

Charles Mallory has skills like Quality System, Quality Assurance, Fda, Capa, Gmp, Pharmaceutical Industry, Validation, Regulatory Affairs, Cross Functional Team Leadership, Technology Transfer, Medical Devices, Biotechnology.

Who are Charles Mallory's colleagues?

Charles Mallory's colleagues are Nelly Philipos, Corrie Roncal, Tricia F. Stewart, Eddie Garcia, Barry Greenberg, Viet-Tam Nguyen, Christine Daniele.

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