At Novartis Radioligand Therapy, my leadership in Site Quality Assurance Operations is defined by dedication to product and process excellence by ensuring stringent quality oversight of production and Quality Control testing, culminating in the final product disposition. This role benefits from my proficiency in PCR, microbiology, and genetics, and encapsulates a commitment to continuous improvement of quality strategies.Previously, as a Senior Manager at Terumo Medical Corporation, I pioneered advancements in medical device complaint investigations and post-market surveillance, directly enhancing patient safety and satisfaction. Our collective efforts contributed to shaping the medical diagnostics landscape, thanks to a forward-thinking approach that leverages innovation within regulatory compliance frameworks.
Novartis Radioligand Therapy
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Head, Site Quality Assurance OperationsNovartis Radioligand Therapy Oct 2024 - PresentResponsible for the quality oversight of Production and Quality Control testing at Millburn, including final disposition of product. Ensure that the quality strategy is implemented and that there is a continuous drive to improve product and process quality.
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Senior Manager, Medical Device Complaints And Post Market SurveillanceTerumo Medical Corporation May 2022 - Sep 2024Somerset, New Jersey, Us -
Sub Chapter Lead - Assays, Complaint Investigation And ResolutionRoche Mar 2022 - May 2022Switzerland 🇨🇠, ChSub Chapter Lead, Assays Complaint Investigation and Resolution -
Senior Manager Case Investigation And ResolutionRoche Oct 2020 - Mar 2022Switzerland 🇨🇠, Ch -
Manager Cobas Liat ReagentsRoche Jun 2017 - Oct 2020Switzerland 🇨🇠, ChDepartment Head RMD cobas Liat Reagents -
Principal Scientist Case Investigation And Resolution Genomics & OncologyRoche Nov 2014 - Jun 2017Switzerland 🇨🇠, Ch -
Department Head Case Investigation And Resolution Blood ScreeningRoche Mar 2013 - Nov 2014Switzerland 🇨🇠, Ch -
Principal Specialist Global Product SupportRoche Jun 2011 - Mar 2013Switzerland 🇨🇠, Ch- Work closely with Affiliate sales and marketing, QA/QC, research and development to address customer concerns, determine corrective action and customer follow-up.- Builds cross-functional coalitions and promote cooperation between various GSS-sites, regions, functions and business areas. Assist in harmonizing processes and participate in global meetings, educational events and seminars programs.- Provides a superior level of product support to worldwide Affiliates for all RMD reagents, software, hardware, instruments, LIS, Connectivity and Hospital IT lines with emphasis on “total systems approach” including technical support, training, Affiliate support, complaint handling and leading special projects. - Serves as a technical product consultant in the RMD Complaint Handling Unit (CHU) of the RMD Complaint Management group for all RMD PCR products.- Processes, investigates, and monitors trending of product defect complaints. Address and expedites product complaints under the company's complaint policy and procedures, and ensures compliance with regulatory agencies. Monitors complaint activity and provides suggestions to appropriate company authorities to modify existing manufacturing or packaging process based upon pattern and related analyses. - Designs, organizes, and executes technical trainings for Affiliates, customers and in-house personnel. Assesses and defines training and performance needs of Affiliates. Performs on-site training when required. Plans, develops, and coordinates in-house product training programs for field support personnel and customers. Obtains information needed to prepare in-house training programs; prepares training materials; develops course content; determines methodology; and coordinates the development of training aids. Conducts training sessions and develops criteria for evaluating effectiveness of training activities. -
Adjunct Professor Of BiologyMiddlesex County College Sep 2008 - Jun 2011Edison, Nj, Us•Instruct lecture and laboratory for a Microbiology course for majors involving microbial genetics, cell and molecular mechanisms, and disease causing situations (BIOLOGY 211: Principles of Microbiology)•Instruct a microbiology class in which non-majors were taught the basics of microbiology (bacteria, fungi, viruses, etc) and their roles in shaping society and the world today (BIOLOGY 104: Mysteries of the Microbial World)•Instruct lecture and laboratory for a General Biology course for science majors studying the basic principles and origin of life, chemistry of living things, cell metabolism, and genetic principles (BIO 123: General Biology I) -
Assistant Professor Of BiologyRamapo College Of New Jersey Apr 2009 - Mar 2010Mahwah, Nj, Us•Instructed lecture and laboratory for a Microbiology course in the nursing program intended at teaching the clinical significance of microorganisms in the environment and in disease causing situations (BIOLOGY 211: Microbiology)•Instructed a first-year Biology laboratory for a Fundamentals course which included a writing-intensive component and dissection of plant and animal physiology (BIOLOGY 101: Fundamentals of Biology)•Took part in weekly journal club meetings aimed at generating scientific discussion of recent publications among undergraduate biology majors•Participated in academic advisement for student regarding major and course selection -
Postdoctoral FellowPbl Biomedical Laboratories Jun 2007 - Aug 2009Piscataway, Nj, Us•Performed biochemical research involving the antiviral activity of different human interferon alpha subtypes•Purified ten novel interferon alpha variant proteins up to 90% purification and performed antiviral cytopathic effect assays to identify agents that inhibit EMCV, VSV, and HIV infections •Conducted in vivo FRET analysis to determine the interaction and binding affinities of several interferon receptors•Mentored college student interns on direct monoclonal antibody ELISA analysis and data collection
Gina Digioia Phd Education Details
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University Of Medicine And Dentistry Of New JerseyMicrobiology And Molecular Genetics -
Drew UniversityNeurobiology
Frequently Asked Questions about Gina Digioia Phd
What company does Gina Digioia Phd work for?
Gina Digioia Phd works for Novartis Radioligand Therapy
What is Gina Digioia Phd's role at the current company?
Gina Digioia Phd's current role is Quality Assurance Leader.
What schools did Gina Digioia Phd attend?
Gina Digioia Phd attended University Of Medicine And Dentistry Of New Jersey, Drew University.
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