Experience

Imugene Limited

• Australia
• Biotechnology Research
• 1 - 100 Employee

• Associate Director External Quality and GxP Training

  • Aug 2023 - Present

  North Carolina, United States



Precision BioSciences, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Associate Director, External Quality & GxP Training (Remote)

  • Apr 2022 - Aug 2023

  Durham, North Carolina, United States Primary Quality contact and lead for the development, maintenance and operation of the External Quality and GxP Training programs for Precision BioSciences. Responsibilities include: External Quality (Supplier, CDMO and Clinical Quality): Act as primary QA contact for External GxP operations. Collaborate with internal groups and project teams to ensure alignment in regards to external GxP operations. Provide QA oversight, management and qualification of CROs, CDMOs, suppliers and… Show more Primary Quality contact and lead for the development, maintenance and operation of the External Quality and GxP Training programs for Precision BioSciences. Responsibilities include: External Quality (Supplier, CDMO and Clinical Quality): Act as primary QA contact for External GxP operations. Collaborate with internal groups and project teams to ensure alignment in regards to external GxP operations. Provide QA oversight, management and qualification of CROs, CDMOs, suppliers and testing vendors, including Quality Agreement process and external audits (planning, tracking, qualification, eTMF, audit responses and closeout). Create, review, approve and/or assist with various Quality documentation, including deviations, CAPA, audit documentation, SOPs, etc. Supervision and coaching of External QA team members. GxP Training: Management of the Precision GxP Training Program. Learning System Management (LMS) administrative activities in the ZenQMS electronic Quality Management System (QMS). Deliver New Employee Orientation Quality training to all new hires. Create, revise, review/approve and deliver GxP training documentation, materials and sessions. Collaborate with Management, Process Owners and SMEs to identify GxP and other training needs and assist with implementation. Assist with other Quality programs and functions as needed (e.g., internal auditing, QMS support, Quality improvement projects, etc.).

• Associate Director, Quality Training

  • Jan 2022 - Apr 2022

  Durham, North Carolina, United States Owner of the Quality and Compliance Training Program for an early-stage clinical cell/gene therapy company. Responsibilities include ZenQMS LMS Administration, facilitation of new hire orientation, design/delivery/coordination of GxP and other company training. Assist with other Quality functions and improvement opportunities as needed (e.g. internal audits, eTMF audits, documentation review, etc.). Quality Representative for LabVantage LIMS deployment project.

• Training Manager

  • Feb 2020 - Jan 2022

  Durham, North Carolina, United States Owner of company Quality and Compliance training program for an early stage clinical cell/gene therapy company. Responsibilities include ZenQMS LMS Administrator, facilitation of new hire orientation, design/delivery/coordination for various types training topics (GLP, GCP, GMP, general Quality, etc.) and methodology, and serve as training SME for project and audits. Assist with other Quality functions as needed (e.g. auditing, documentation review, etc.).



o2 fitness

• Colombia
• Spectator Sports
• 1 - 100 Employee

• Group Fitness Instructor (Raleigh-area locations)

  • Feb 2012 - Dec 2021

  Raleigh-Durham, North Carolina Area Certifications: Les Mills BODYCOMBAT and BODYPUMP, IFTA Group Fitness and Personal Trainer



Sagent Pharmaceuticals

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr. Training Specialist

  • Apr 2019 - Feb 2020

  Raleigh, North Carolina (Former Xellia Pharmaceuticals site acquired by Sagent in January 2020) Responsible for Site training program, including LMS administration, new hire orientation and design/delivery of cGMP training.



Purdue Pharma L.P.

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Quality Specialist I, Training Administration

  • May 2018 - Apr 2019

  Wilson, North Carolina Owner of GxP training program for Wilson and Durham NC Sites, success Factors LMS Administrator, new hire orientation facilitation



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Training Manager

  • Oct 2011 - May 2018

  Morrisville, NC Responsible for oversight of Site training program, including new hire orientation, ComplianceWire Learning Management System administration, training curriculum creation and management, design and delivery of training, needs and effectiveness assessments. Supervision of Training/Operational Excellence staff. Liaise with Site departments and Leadership to continuously assess and revise training requirements to match regulatory, customer and internal requirements. Management of learning… Show more Responsible for oversight of Site training program, including new hire orientation, ComplianceWire Learning Management System administration, training curriculum creation and management, design and delivery of training, needs and effectiveness assessments. Supervision of Training/Operational Excellence staff. Liaise with Site departments and Leadership to continuously assess and revise training requirements to match regulatory, customer and internal requirements. Management of learning opportunities through North Carolina Community College System grant program. Show less



Life Time Fitness

• Saudi Arabia
• Sporting Goods Manufacturing
• 1 - 100 Employee

• Group Fitness Instructor (Plantation Point Location)

  • Feb 2012 - Aug 2012

  Raleigh, NC Helping to promote Life Time's mission to provide an "educational, entertaining, friendly and inviting, functional and innovative experience of uncompromising quality that meets the health & fitness needs of the entire family." Formats: Indoor Cycle



Grifols Inc (Formerly Talecris Biotherapeutics)

• Sr. Training Coordinator, R&D QA

  • Sep 2009 - Oct 2011

  Raleigh, NC Training development, management, assessment, design and delivery for R&D associates within a GXP environment. Partner with R&D groups and Performance Development to raise engagement and training compliance. Administrator Role in Kaplan Eduneering ComplianceWire LMS, with responsibility for R&D. Participating on Project Team for first time device (IVD) design and development for company. Project work includes creation and maintenance of a Development Change Control system, DHF setup… Show more Training development, management, assessment, design and delivery for R&D associates within a GXP environment. Partner with R&D groups and Performance Development to raise engagement and training compliance. Administrator Role in Kaplan Eduneering ComplianceWire LMS, with responsibility for R&D. Participating on Project Team for first time device (IVD) design and development for company. Project work includes creation and maintenance of a Development Change Control system, DHF setup and maintenance, training tracking and sourcing for team. R&D Representative for Enterprise Content Management project to facilitate collaboration, knowledge management and change control using Documentum CenterStage. Show less



Talecris Biotherapeutics, Inc.

• United States
• Biotechnology
• 200 - 300 Employee

• R&D QA Training & Records Management Specialist

  • Jul 2009 - Sep 2009

  (Contract through Accentuate Staffing, Inc.) Training development, management, and delivery for R&D associates within a GXP environment. Partner with R&D groups and Performance Development to raise engagement and training compliance. Assist in company-wide implementation of ComplianceWire LMS.



Closure Medical/Ethicon Inc.

• RA Associate/Training Associate

  • Oct 2006 - Jul 2009

  International Regulatory Registration, Labeling Coordination Continued training role until April 2009



Closure Medical

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Manufacturing Training Coordinator

  • Nov 2004 - Oct 2006

  Oversight and administration of Manufacturing departmental training program.

• QA Technologist

  • Feb 2003 - Oct 2004

  Batch record review and release, management of product retains, internal auditing, backup for document and CAPA systems administration.