Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Erin Driggers

Wendell

Summary

Dynamic quality leader with extensive experience at Uniphar Group, excelling in quality management systems and regulatory compliance. Proven track record in root cause analysis and process mapping, driving significant improvements in operational efficiency. Adept at vendor management and fostering collaborative relationships, ensuring compliance with GxP standards across multi-site operations.

Overview

22
22
years of professional experience
1
1
Certification

Work History

Head of Quality - Contract

Uniphar Group
05.2023 - 05.2024
  • Ground-up build of 3PL, wholesaler and clinical services facilities
  • Build of consolidated US multi-site QMS per GxP requirements, including SOP writing and process mapping
  • Designated Representative for Wholesaler Licenses in 50 states
  • State licensing applications, regulatory representative and feasibility liaison
  • Responsible for ensuring 21CFR and GAMPV compliance

Director of Quality - Contract

CCL Label
10.2022 - 05.2023
  • Re-design and maintain QMS, to bring in line w/ISO 9001 and GMP expectations
  • Introduced process-mapping and continuous improvement techniques
  • Consolidating 13 individual QMS into a single streamlined entity
  • Introduced root-cause analysis techniques for non-conformance investigations

Regional QA Director, NORAM

Marken
01.2020 - 10.2022
  • Manage Global QMS for Marken/UPS.
  • Primary feasibility representative for all new projects, providing QA and Regulatory guidance
  • Redesigned electronic platform for Investigations, including CSV.
  • Manage a multi-site team covering 4 logistics branches and 2 GMP depots
  • Implement Technical / Quality Agreements with an international array of vendors
  • SME for Root Cause Analysis initiative across global department
  • Project management lead for QMS improvement initiatives

Manager, Supplier Quality

Almac Clinical Services
04.2011 - 01.2020
  • Manage vendor network for 3 facilities in US and UK.
  • Perform 20+ international audits yearly as lead auditor, against FDA, MHRA, EU, and ISO regulations/standards, as well as 21CFR 210 & 211
  • RABSQ certified ISO 9001 Lead Auditor
  • Built global Supplier Quality department from scratch
  • Implement Technical / Quality Agreements with an international array of vendors
  • Administrator for electronic LMS and electronic document depository.

Supervisor, Quality Control/Investigations

Hospira
04.2009 - 04.2011
  • Managed quality investigations group for QC laboratory
  • Analytical testing to include RM, FP and PV testing/plans
  • Supported In-Process & Finished Product Release
  • Expert in root-cause analysis and FMEA
  • Managed raw materials department for 1 year
  • Responsible for 10-15 chemists and investigation writers
  • Primary point of contact for LIMS implementation initiative
  • Assisted in Annual Product Quality Reviews

Supervisor, Quality Control

Sandoz
03.2008 - 04.2009
  • Responsible for 15 chemists supporting FP/Stability/Process Validation testing.
  • Led efforts to reduce cycle time by 50%.
  • Implemented efficiency improvement initiatives concerning HPLC data packets, sample tracking, and specialization of testing.
  • Managed stability program for Metoprolol portfolio
  • Database Administrator for Millenium/Empower network

Supervisor, R&D

Leiner Health Products, LLC
03.2005 - 03.2008
  • Database Administrator for Millenium, responsible for data back-up and integrity, project creation and training.
  • Served as primary technical contact for all interactions with customers and contractors.
  • Proficient in application of ICH, FDA, and CDER guidelines to development and validation.
  • Prepared technical reports and summaries directly reportable to FDA.
  • Recognized by FDA investigators for technical expertise.
  • Coordinated the training of all QA Analysts by devising a training plan for each individual.
  • Wrote validation protocols, method development reports, method transfers, and validation final reports.

Chemist III, Quality Control

Chesapeake Biological Laboratories
01.2004 - 03.2005
  • Responsible for quality control testing, release and stability testing of sterile-injectable products.
  • Millennium database administrator, involving data back-ups and data integrity management.
  • Maintained and calibrated most lab equipment, including HPLCs and TOC testers.

Quality Control Chemist II

IVAX Pharmaceuticals
04.2002 - 12.2003
  • Performed all QC analytical techniques utilizing HPLC via TurboChrom software.
  • Proficient in performing both isocratic and gradient HPLC methods.
  • Developed a thorough understanding of USP guidelines.
  • Experienced in both performing experiments and reviewing other individuals’ documentation.
  • Self-taught and demonstrated expertise in chromatography techniques and instrumentation.
  • Promoted from Q/C Chemist I to Chemist II after only 3 months.

Education

Bachelor’s Degree - Chemistry

Florida International University
Miami, Florida

Skills

  • Quality management systems
  • Regulatory compliance
  • Root cause analysis
  • Process mapping
  • Technical agreements
  • Vendor management

Certification

  • NC Regulatory Affairs Forum preparatory course
  • RABSQ Certified ISO 9001 Lead Auditor

Timeline

Head of Quality - Contract

Uniphar Group
05.2023 - 05.2024

Director of Quality - Contract

CCL Label
10.2022 - 05.2023

Regional QA Director, NORAM

Marken
01.2020 - 10.2022

Manager, Supplier Quality

Almac Clinical Services
04.2011 - 01.2020

Supervisor, Quality Control/Investigations

Hospira
04.2009 - 04.2011

Supervisor, Quality Control

Sandoz
03.2008 - 04.2009

Supervisor, R&D

Leiner Health Products, LLC
03.2005 - 03.2008

Chemist III, Quality Control

Chesapeake Biological Laboratories
01.2004 - 03.2005

Quality Control Chemist II

IVAX Pharmaceuticals
04.2002 - 12.2003

Bachelor’s Degree - Chemistry

Florida International University

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Erin Driggers