2023 -now Quality System Consultant @ Spotlight Quality LLC
2023 -2024 GxP Quality Consultant @
2021 -2023 Director of GMP Quality Systems @
2021 -2023 Director Quality System @
2020 -2021 Head of Quality @
2019 -2020 Consultant - GxP Quality Systems and Inspection Readiness @
2019 -2020 Quality Consultant @ Softworld Vita Data Sciences
2019 -2019 Associate Director - Quality Systems, Compliance and Validation @
2017 -2019 Director and Associate Director, Quality Management Systems @
2015 -2017 Sr. Manager Quality Systems @
2015 -2017 Quality System Manager @
Heather McCormick Education
Southern New Hampshire University
Bachelor of Science - BS (Bachelor of Science, Organizational Behavior Studies)
2014-2017
Heather McCormick Skills
Microsoft PowerPoint
SOP Development
Records Management
ICH
Virtual Teams
Third Party Inspection
Regulatory Compliance
Investigational New Drug Application (IND)
New Drug Application (NDA)
MHRA
Data Integrity
Software Development Life Cycle (SDLC)
Root Cause Analysis
Supplier Quality Management
Continuous Process Improvement
Vendor Management
Start-ups
Project Management
21 CFR Part 11
CAPA
Change Control
Document Management
FDA
GAMP
GCP
GMP
Leadership
Quality Assurance
Quality Management
Quality System
Quality System Compliance
Software Documentation
Training
Validation
Internal Audit
ICH Guidelines
Consent Decree
SOP
Biotechnology
Biopharmaceuticals
Medical Devices
GxP
GLP
Life Sciences
Regulatory Affairs
Standard Operating Procedure (SOP)
U.S. Title 21 CFR Part 11 Regulation
U.S. Food and Drug Administration (FDA)
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
Quality Control
Performance Management
Technology Transfer
Manufacturing
MRB
Quality Systems
Documentation
ERP
Annual Product Review
Staff Training
Personnel Supervision
Complaint Handling
Complaint Management
Pharmaceutical Industry
Personnel Management
Management
Car Care/Car Wash
Scratch Repair
Data Management
Opti Coat Pro Specialists
Clinical Data Management
Good Clinical Practice Gcp
Auto Paint Restoration
Corrective and Preventive Action Capa
Auto Detailing
Headlight Restoration and Repair
Wax Specialists
Dent and Hail Damage Repair
Windshield Repair
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Metrics
Rv Wash and Detail Services
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Good Clinical Practice
Heather McCormick Summary
Heather McCormick, based in Glen Allen, VA, US, is currently a Director, Quality Systems and Compliance at Pliant Therapeutics. Heather McCormick brings experience from previous roles at Spotlight Quality, LLC, Spotlight Quality LLC, Conjugate Group and Akouos. Heather McCormick holds a 2014 - 2017 Bachelor of Science - BS in Bachelor of Science, Organizational Behavior Studies @ Southern New Hampshire University. With a robust skill set that includes Microsoft PowerPoint, SOP Development, Records Management, ICH, Virtual Teams and more. Heather McCormick has 2 emails and 1 mobile phone numbers on RocketReach.
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