Carrie Fitzgerald

SENIOR CONSULTANT

A Quality professional with 20+ years’ experience in biotech, small molecules and medical devices with expertise in establishing quality systems, hosting regulatory inspections, auditing, root cause analysis, CAPA, change management, product lot release, quality agreements and training.

About Carrie

Carrie’s first position after graduating from California Polytechnic University was at PriSMedical Corporation, a medical device company, where she followed their first 510(k) cleared product through its entire lifecycle, from research and development to commercial scale manufacture at a contract manufacturer. She also grew over this time, evolving from a laboratory technician to Manager of QA/QC. During this same time, she received a US patent for a drug delivery device, was a co-author on a peer reviewed publication, assisted in the preparation and hosting functions for the company’s first pre-market inspection, then acted as the primary host for the subsequent FDA re-inspection for which there were no 483 observations issued.

Carrie then transitioned from medical devices to a clinical stage biotechnology company, XOMA Corporation.  There she continued her growth in Quality Assurance. Carrie’s leadership, organizational skills and attention to detail on Quality principals were recognized as she was promoted from QA Associate II to Associate Director of Quality Assurance/Quality Control/Quality Engineering in a short period of time. Carrie’s responsibility was to ensure GMP/GLP compliance throughout the company by effectively managing systems, projects and teams.

From XOMA Carrie moved to Genentech, Inc. Vacaville, CA (a member of the Roche group) to further her growth within the commercial space as part of the Site Compliance team. There Carrie had the opportunity to work both with cross-site and global teams to prepare for Health Authority inspections.  In addition to preparing and hosting inspections, she worked with experts in all areas of the site to provide strategy for presenting topics, identify and reduce compliance risks and provide written compliance opinions. Carrie was also recognized by Roche as an outstanding auditor and trainer when she was asked to be a facilitator for their 5-day intensive Internal Auditor Training Program. Through this program she got the opportunity to travel to different geographies and share her knowledge and love of auditing.

After Genentech Carrie came full circle and joined a medical device company, Cerus Corporation. What primarily attracted her to this role was the opportunity to expand her knowledge of medical device regulations and to be a part of a team to bring new products to market. At Cerus Carrie led a QA department responsible for GLP, GMP and GCP compliance of developing products that must not only meet medical device, drug product and biologics regulations, but those from a variety of regulatory agencies around the world since Cerus’ products are sold in many different geographies. In addition to the complexities of the regulatory landscape, all GMP production is outsourced to contract manufacturers, for which she was also responsible to ensure compliance.

Bringing with her a broad range of GxP experience for both developing and commercial products, Carrie joined Dark Horse in 2022.

CAREER HIGHLIGHTS

  • QA lead for development and commercialization of Pathogen Reduced Cryoprecipitated Fibrinogen Complex, FDA approval granted November 2020
  • Author and reviewer of CE Mark dossier and FDA IDE applications for the Red Blood Cell program
  • Author of CMC Quality sections and provided technical review for of gevokizumab BLA, IND and international filings
  • Inspection readiness lead for pre-approval inspection of Ocrevus
  • Successful tech transfer and process validation of phase 3 gevokizumab API and drug product
  • Renovation and commissioning of GMP facility, including responsibility for utilities qualification and environmental monitoring program

PAST EXPERIENCE

Cerus Corporation
Associate Director, Quality Assurance

Genentech, Inc.
QA Senior Specialist, Site Compliance

XOMA Corporation
Associate Director Quality Assurance/Quality Control/Quality Engineering

PriSMedical, Corporation
Manager, Quality Assurance/Quality Control

CERTIFICATIONS

BSI Certification

  • Management Systems Auditing (ISO 19011:2018) January 2019
  • Leading Management Systems Audit Teams (ISO 19011:2018) February 2019
  • Medical Devices Quality Management Systems (ISO 13485:2016) January 2019
  • ISO 13485:2016 Lead Auditor (TPECS) February 2019

American Society for Quality

  • Certified Quality Auditor (CQA) Certification Date: 12/02/06 and 10/06/17

EDUCATION

California Polytechnic State University, San Luis Obispo, CA
B.S. in Biology 1998

UC Berkeley Extension
Drug Development Seminar December 2014
BUS ADM X470 Project Management February 2015

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