Summary
Overview
Work History
Education
Skills
Industry Groups
Timeline
Generic

Eric Bell

Moore,OK

Summary

Improvement-oriented professional with 25 years of experience in Quality, Regulatory, Laboratory, and Manufacturing Operations. Hosted or actively participated in 20 FDA inspections (CBER and CDER), and several ISO and supplier audits. Extensive background in Quality Risk Management, Pharmaceutical Quality Systems, GMP for Active Pharmaceutical Ingredients, Change Control, Investigations and CAPA, Pharmaceutical Development and Manufacturing.

Overview

27
27
years of professional experience

Work History

Senior Director of Quality, Site Quality Head

Cytovance Biologics
04.2021 - Current
  • Member of company’s Senior Leadership Team representing all Quality functions.
  • Leads departments consisting of 95 personnel.
  • Primary driver in company for turnaround and repair of key commercial client relationship.
  • Reformed Validation Team with reorganization efforts, creating efficient and driven team of validation professionals.
  • Led expansion of QC Laboratories, adding to capabilities to enhance profitability.
  • Fostered work culture of collaboration and inclusion to increase morale and reduce turnover.
  • Set and administered $9.8M yearly budget with no overages.

Senior Director, Quality Assurance

Cytovance Biologics
01.2019 - 04.2021
  • Lead QA Team of 34 for rapidly growing biologics CDMO that successfully prepared for 2 pre-approval inspections (1 biosimilar and 2 in vitro blood grouping reagents)
  • Removed silos and built strong relationships with cross-functional groups throughout company.
  • Drove strategic improvements to enhance operational and organizational efficiencies
  • Established departmental performance goals and provided feedback for underperforming areas

Director of QA

Cytovance Biologics
01.2017 - 12.2018
  • Responsible for QA Operations, QA Incoming Inspection/Sampling, QA Compliance and Regulatory and Document Control
  • Cleared large backlog of past-due investigations and CAPAs.

QA Manager

Cytovance Biologics
05.2016 - 12.2016

Director of Quality Assurance and Regulatory Affairs

Allergy Laboratories, Inc. (ALK-Abello)
12.2014 - 05.2016
  • Implemented high-level policies and procedures for expanding pharmaceutical company
  • Focused on process of building and stabilizing organization with appropriate staff to ensure long-term success of company.
  • Improved compliance of investigation and CAPA systems.
  • Implemented metrics approach to improve focus and productivity of deviation and CAPA systems.
  • Implemented Quality Management System.
  • Annual Product Quality Report (APQR) System
  • Correspondence with regulatory bodies

Quality Control Manager

Allergy Laboratories, Inc. (ALK-Abello)
04.2006 - 12.2014
  • Management of Analytical and Microbiology QC Laboratories
  • Environmental monitoring (sterile filling/aseptic processing)
  • Risk assessment, Change Control
  • Failure and deviation investigations
  • Correspondence with FDA/CBER for product release and deviations (eBPDR)
  • Documentation review
  • Equipment Qualification, Facility and Process Validation
  • Internal and External Audits.

QA Specialist III

Allergy Laboratories, Inc. (ALK-Abello)
07.2005 - 04.2006

R&D Scientist (Hemostasis)

BioMérieux Inc.
11.2003 - 05.2004
  • Execution of studies for in vitro diagnostics instrumentation, testing kits and reagents
  • Data analysis
  • Report preparation

QC Supervisor

BioMérieux Inc. / Organon Teknika Corp.
12.2001 - 11.2003
  • Managed QC personnel (5-6 associates with technical backgrounds)
  • Coordinated international instrument reliability groups
  • Coordinated failure investigations
  • Represented QA/QC in FDA, ISO audits
  • Reviewed all instrument history records for approval & release.

QC Specialist / Nucleic Acid Program Group leader

BioMérieux Inc. / Organon Teknika Corp.
10.1996 - 12.2001

Education

Bachelor of Science - Microbiology -

University of Oklahoma
05.1997

Skills

  • Culture Transformation
  • Core Values Management
  • Team Building and Motivation
  • Operations Management
  • Policy Implementation

Industry Groups

  • Allergen Products Manufacturers Association (APMA) – Past Vice President
  • Parenteral Drug Association (PDA) – Member
  • American Society for Quality – Member
  • International Society of Pharmaceutical Engineers (ISPE) - Member

Timeline

Senior Director of Quality, Site Quality Head

Cytovance Biologics
04.2021 - Current

Senior Director, Quality Assurance

Cytovance Biologics
01.2019 - 04.2021

Director of QA

Cytovance Biologics
01.2017 - 12.2018

QA Manager

Cytovance Biologics
05.2016 - 12.2016

Director of Quality Assurance and Regulatory Affairs

Allergy Laboratories, Inc. (ALK-Abello)
12.2014 - 05.2016

Quality Control Manager

Allergy Laboratories, Inc. (ALK-Abello)
04.2006 - 12.2014

QA Specialist III

Allergy Laboratories, Inc. (ALK-Abello)
07.2005 - 04.2006

R&D Scientist (Hemostasis)

BioMérieux Inc.
11.2003 - 05.2004

QC Supervisor

BioMérieux Inc. / Organon Teknika Corp.
12.2001 - 11.2003

QC Specialist / Nucleic Acid Program Group leader

BioMérieux Inc. / Organon Teknika Corp.
10.1996 - 12.2001

Bachelor of Science - Microbiology -

University of Oklahoma

Similar Profiles

CREATE PROFILE
Eric Bell