1. BSc
Mjr: Biological Sciences (Microbiology)
Mnr: Applied Mathematics
Biologist III
Biologist II
MBA (Honors)
General Business Administration
Finance
QA Auditor III
QA Auditor II
Senior QA Auditor
QA Manager
QA Manager
Program Lead
Senior QA
Manager
Microbiological Associates / MA BioServices / Invitrogen / BioReliance MSDPurdue University
Keller Graduate School
Quality
Systems
Manager
Quality
Engineer
Lean Six Sigma
Lead II
Senior Lean
Six Sigma
Lead
Senior
Manager
Manufacturing
Technical
Operations
MedImmune / AstraZeneca
94 95 96 97 98 99 00 01 02 03 04 05 0690 91 92 9388 89 07 08 09 10 11 12 13 14 15 16 17
Quality Assurance
Quality Systems
Quality Engineering / Validation
Continuous Improvement
ASQ
Certified Quality Engineer
Senior
Quality
Engineer
John
Wilkes
Biology Cell Culture Propagation In Vitro Cell Culture Assays Field / Supplier/ Client / Regulatory Audit & Inspection GLP cGMP QSR ICH Compliance Alliance Management
Deviations Non-conformances CAPA Change Management Document Management Management Review Metrics Compliance Design Implementation Management
Computer Systems Laboratory Systems Equipment Facility / Utilities Compliance Oversight Configuration Control Design ControlProject Management
Measurement & AnalysisProblem Solving Error Reduction Training Design Training Delivery Human Performance
ERP System
Validation
Quality Management
System Implementation
Quality Management
System Validation
Quality Management
System Improvement
Laboratory Management
System Validation
Manufacturing Facility
Commissioning & Validation
Regulatory Risk
Reduction
Human Performance
Program
Projects&Contributions
Test Script
Execution
Quality Review
Problem Analysis
Implementation Lead
QMS Process Design
Global Harmonization
Change Management
Business Process Design
Requirements Definition
Vendor Qualification
Training Design & Delivery
Validation Leadership
Protocol Design
Test Script Design
Execution Management
Quality Oversight
Problem Resolution
Problem Analysis
Stakeholder Engagement
Business Process
Improvement
Implementation and
Change Management
Validation Leadership
Protocol Design
Test Script Design
Execution Management
Quality Oversight
Problem Resolution
Compliance Oversight
Quality Audit
System Review & Release
Observation
Resolution
CAPA execution
and closure
Master Plan
Change Management
Training Design
Training Delivery
Error reduction tools
and work practices
Procedure design
improvement
Biology
Quality Assurance
Quality Systems
Quality Engineering/Validation
Continuous Improvement
Personality
Committed to Learning
Improvement Focused
Data Driven
Tenacious
Expansive Thinker
Detail Oriented
Highly Creative
Pragmatic
Logical
Goal Oriented
Detailed Planner
Important to Me
Family: Married w/two children
Wife – Jennifer
Son – Noah 14yr
Daughter – Madeleine 11yr
3 dogs – Duke (Bassett Hound),
Willie, & Ladybug (Dachshunds)
Passions & Interests:
Baseball – Chicago Cubs
Cooking and Eating
Working in the yard
History
Golfing and poker with friends
RESILIENCE FOCUSED
To build organizational
resilience through the
integration of best practices
in Quality Systems and
Operations Performance
Quality Systems Design &
Management
Continuous Improvement
Human Performance
Focus and Vision
John Wilkes is a Senior Manager for AstraZeneca in the manufacturing technical operations team. His focus is on:
Leading a team of investigators with a focus on mitigating risk and improving the resilience of
operations through the identification of failure causes and the development of targeted solutions.
Developing and implementing the use of learning teams and knowledge assets.
Improving the performance and utilization of site quality systems in order to strengthen the
organization’s risk profile.
Implementing and applying concepts and principles of human performance to reduce the incidence of
human error and the consequences associated with it.
jwilkes023@msn.com Linkedin.com/in/jowilkesM: 301-455-3109