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Director, PPM, Enterprise Q&C
#CAPA #FDA #QualitySystem
#NorthAmerica
Senior Quality Systems Program Manager who leads complex, large-scale process re-engineering transformations across matrix organizations to drive high-priority initiatives to achieve delivery and oper
Senior Director, Cambridge Pharma
#QualitySystem #InjectionMolding
#Europe
Over 24 years of experience in manufacturing/new product development/product life cycle management and commercialization specializing in the medical device, pharmaceutical/biotech industry.
Director of Regulatory Affairs & Quality
#medicaldevice #qualitysystem
#Northamerica
Caroline Kirwan is currently working as Director of Regulatory Affairs & Quality at Cumulus Neuroscience.
Manager, Post Market Surveillance
#quality #compliance #qualitysystem #medicaldevices
Dara Friedman is currently a post market surveillance manager for Stryker’s medical division. She earned her bachelor’s degree fromMichigan State University, and her MBA from Webster University.
Executive Director, Global Digital Quality Management Systems and Business Intelligence
#qualitysystem
Irene Szeto is a results-oriented professional with a remarkable background in Global Quality Compliance, Business Intelligence, Health Authority Inspection, and various regulatory aspects such as SOX
Strategic Analytical Validation & Lifecycle Lead
#lims #qualitysystem
Jean is currently working as a Strategic Analytical Validation & Lifecycle Lead at GSK
Vice President Quality and Qualified Person
#qualitysystem #gmp #qualityassurance
#Germany
Graduated in Pharmacy from the University TübingenMore than 20 years leadership experience in Quality Management within the Pharmaceutical and Medical Device Industry and Pharmaceutical Distribution,
Regulatory Policy, Head North America Region
#qualitysystem #iso13485
Lina started her career at the FDA Office of New Drugs. Her tenure at FDA enabled her to gain a firm grasp of regulatory and scientific issues impacting drug development. From there she joined the Mer
Vice President, US Cell Therapy Operations
#celltherapy #qualitysystem
An accomplished Quality Management leader with over 20 years of broad experience in multi-national organizations within the Pharmaceutical, Medical Device, Biotech and Cell Therapy industries. Strateg
MEP
#qualitysystem #validation
Ondrej Knotek has been a Member of the European Parliament from the Czech Republic since 2019, focusing on regional development, the environment, public health and food safety.
Senior Consultant
#Asia
11 years of IT experience, designing solutions and formulating requirements for US Health plans. Effectively able to translate business vision into technical specifications, analyzing impact holistica
Associate Director, Global Regulatory Affairs & Compliance - QMS
Highly motivated, result driven Quality Engineering Professional with over 17 years of experience in FDA and CE regulated Medical Devices, Combination Products and SaMDs. Recognized for ability to lea