Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Daniel Brandt

Pueblo West,CO

Summary

Seasoned Quality Systems professional with 7 years of experience managing global quality systems across multiple sites for two Fortune 100 pharmaceutical companies, specializing in company acquisitions, enterprise systems, and internal QA processes. Prior to this, I spent 9 years in pharmaceutical product development, focusing on intermediates and APIs. Since 2014, I have been building Quality Systems and offering QA, product development, and business consulting services in regulated industries.

Overview

18
18
years of professional experience

Work History

Quality Systems Consultant

Elite Project Consulting
Pueblo West, CO
10.2014 - Current
  • Lead QMS migration and implementation projects, ensuring compliance with industry standards and improving efficiency.
  • Develop and standardize policies, SOPs, production records, forms, and other business critical documents, resulting in reduced errors and improved quality assurance.
  • I’m partnered with eQMS solution providers to integrate cloud-based systems, leverage AI tools, and enhance document control and management processes.

Quality Systems Editor

AbbVie
Abbott Park, IL
01.2013 - 01.2014
  • Evaluate Quality Systems of potential acquisitions to assess compatibility when compared to our own QS.
  • Work with IT to develop enterprise systems for quality systems management, personnel training, CAPA tracking, and more.
  • Coordinate global and multi-site projects while maintaining compliance to all applicable regulations, US and others.
  • Create QS elements and processes (expanding the QS framework) for newly acquired sites, divisions, and departments.

Quality Systems Specialist

Abbott Laboratories
Abbott Park, IL
03.2007 - 01.2013
  • Provide support, process improvement, and project management for quality systems.
  • Manage document creation, migrations, translations, implementations, and transitions on a global scale.
  • Manage document change control using a quality systems database to manage translations and multi-site documents.
  • Resolve complex issues/non-conformities for Quality Systems using the CAPA process
  • Write and execute validation protocols for various quality systems.
  • Manage material specification, clinical and device documentation, test methods and reports, and batch records

Education

Biological Sciences

University of Wisconsin, Parkside
Kenosha, WI
06-2010

Skills

  • GMP
  • Internal Audits
  • Quality Systems
  • Quality Management
  • Change Management
  • Enterprise Software
  • GCP
  • GLP
  • GxP
  • GVP
  • Clinical Documentation
  • Medical Devices
  • Records Management
  • Acquisitions
  • Systems Migrations
  • Technical Writing
  • Personnel Training
  • Document Standardization

Accomplishments

In 2013 I received the Abbott R&D Excellence Award for driving the R&D Global Documentation Management Improvement Project. The result of this project was the creating of the new Quality System framework for a new company; AbbVie.

Also, in 2013, I received the Abbott Gold Award for meeting year-end project deadlines in the Abbott/AbbVie Separation Project which included the migration, revision, and creation of over 400,000 documents in over 30 sites globally and creating a new Quality System framework that will be used company wide.

In 2012, I received the Abbott President's Award for meeting the Safety Excellence Program project deadline ahead of schedule and leading to no observations in the MHRA audit of the Abbott Clinical division.

Timeline

Quality Systems Consultant

Elite Project Consulting
10.2014 - Current

Quality Systems Editor

AbbVie
01.2013 - 01.2014

Quality Systems Specialist

Abbott Laboratories
03.2007 - 01.2013

Biological Sciences

University of Wisconsin, Parkside

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