Giulia Paggiola, PhD

Head of Quality & Regulatory Affairs at Clue by Biowink
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Contact Information
us****@****om
(386) 825-5501
Location
CH
Languages
  • Italian Native or bilingual proficiency
  • Portuguese Native or bilingual proficiency
  • English Full professional proficiency
  • Spanish Elementary proficiency
  • German Elementary proficiency

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Eduardo Falabella

Giulia is a brilliant youg PhD student, fluent in several languages who is developing an excellent thesis in the field of Green Chemistry.

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Credentials

  • Leading complex projects
    IDEO U
    Feb, 2022
    - Nov, 2024

Experience

    • Germany
    • Wellness and Fitness Services
    • 100 - 200 Employee
    • Head of Quality & Regulatory Affairs
      • Sep 2021 - Present

      Person Responsible for Regulatory Compliance PRRC for Clue, the medical-grade femtech app (CE-marked and FDA-cleared SaMD containing Class I and Class II device features). Team lead including areas of product regulatory strategy, agile design and development controls, quality KPIs and operations, internal audits, postmarket surveillance.

    • Senior Quality & Regulatory Compliance Manager
      • Aug 2020 - Sep 2021

      Responsible for QMS implementation according to international standards ISO 13485, ISO 14971, ISO 62304. Quality, risk and regulatory compliance for digital health product - software as medical device (SaMD) product.

    • Germany
    • Personal Care Product Manufacturing
    • 1 - 100 Employee
    • EHS & Sustainability Advisor
      • Jun 2020 - Aug 2020

      Environmental, health, safety and sustainability assessment of ingredients of plant based cosmetic formulations Environmental, health, safety and sustainability assessment of ingredients of plant based cosmetic formulations

    • United Kingdom
    • Business Consulting and Services
    • 1 - 100 Employee
    • Regulatory Compliance Specialist
      • Jul 2018 - Jun 2020

      Advising on market access strategy and supply chain compliance for novel cannabis-based products, incl. drug-device combination products, delivery devices, licensed medicines, extract preparations, APIs, novel food supplements, cosmetics, wellness. Advising on market access strategy and supply chain compliance for novel cannabis-based products, incl. drug-device combination products, delivery devices, licensed medicines, extract preparations, APIs, novel food supplements, cosmetics, wellness.

    • United Kingdom
    • Health, Wellness & Fitness
    • 1 - 100 Employee
    • Quality Manager
      • Oct 2017 - Sep 2018

      QMS implementation and regulatory affairs for Software as Medical Device (SaMD) product that uses AI to detect early signs of dementia. Compliance to international standards (ISO13485, ISO14971, IEC62304, ISO14155) and EU (MDD/MDR) and US market (QSR). Technical files for CE marking, FDA, and MHRA clinical trial. QMS implementation and regulatory affairs for Software as Medical Device (SaMD) product that uses AI to detect early signs of dementia. Compliance to international standards (ISO13485, ISO14971, IEC62304, ISO14155) and EU (MDD/MDR) and US market (QSR). Technical files for CE marking, FDA, and MHRA clinical trial.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Project Coordinator
      • Jan 2017 - Sep 2017

      ReMedIES Project lead - industry/academia partnership between GSK and University of Cambridge. Developed digital capability to inform decisions around environment-health-safety and process efficiency in drug manufacture and end-to-end supply chain.

    • Senior Scientist
      • Jan 2016 - Dec 2016

      Environment Health Safety & Sustainability (EHSS) performance monitoring and advisory for drug discovery projects. Part of Green Chemistry team, we focused on promoting sustainability culture across global R&D.

    • Sweden
    • Research Services
    • 300 - 400 Employee
    • Associate Researcher
      • Jan 2015 - Dec 2015

      Developed and validated a combined supply-chain mapping / EHS assessment method for bio-based chemicals. Researched bioeconomy drivers as part of Brazilian innovation system by SENAI, on the model of German Fraunhofer Institutes. Developed and validated a combined supply-chain mapping / EHS assessment method for bio-based chemicals. Researched bioeconomy drivers as part of Brazilian innovation system by SENAI, on the model of German Fraunhofer Institutes.

    • United Kingdom
    • Higher Education
    • 700 & Above Employee
    • Doctoral Researcher
      • Oct 2012 - Sep 2015

      Green Chemistry Centre of Excellence Supervisor: Prof. James H. Clark Project funding: EU Innovation Medicine Initiative Researched the industrial viability of bio-based solvents as alternatives to classic petrochemical ones in pharmaceutical manufacturing. Process optimisation and study of drivers&barriers for change in Pharma. Case study project with Pfizer. Green Chemistry Centre of Excellence Supervisor: Prof. James H. Clark Project funding: EU Innovation Medicine Initiative Researched the industrial viability of bio-based solvents as alternatives to classic petrochemical ones in pharmaceutical manufacturing. Process optimisation and study of drivers&barriers for change in Pharma. Case study project with Pfizer.

    • Founder & President
      • Jul 2014 - Jul 2015

      Started and led a successful cross-disciplinary student community at University of York themed around global sustainability challenges. Fundraising, volunteering, event management, campaigning, networking. Started and led a successful cross-disciplinary student community at University of York themed around global sustainability challenges. Fundraising, volunteering, event management, campaigning, networking.

    • United Kingdom
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Intern - Analytical Quality Control
      • Sep 2013 - Dec 2013

      Trained on high-throughput process technology and analytical methods for screening reagents, catalysts, solvents for the chemical industry. Advanced data analysis and reporting. Trained on high-throughput process technology and analytical methods for screening reagents, catalysts, solvents for the chemical industry. Advanced data analysis and reporting.

    • United States
    • Manufacturing
    • 700 & Above Employee
    • Intern - Corporate Social Responsibility
      • Jun 2012 - Sep 2012

      Project: Wella Committed Beyond Beauty - Gathered qualitative and quantitative data on chemical-heavy practices in hair salons. - Developed a handbook of tips for hair professionals on how to reduce their environmental impact, waste and costs. - Presented results to CSR leadership at P&G headquarters in Geneva. Project: Wella Committed Beyond Beauty - Gathered qualitative and quantitative data on chemical-heavy practices in hair salons. - Developed a handbook of tips for hair professionals on how to reduce their environmental impact, waste and costs. - Presented results to CSR leadership at P&G headquarters in Geneva.

Education

  • University of York
    Doctor of Philosophy - PhD, Chemistry
    2012 - 2016
  • University of York
    Master's Degree, Green Chemistry and Sustainable Industrial Technology
    2011 - 2012
  • Università degli Studi di Modena e Reggio Emilia
    Bachelor of Science (BSc), Chemistry
    2007 - 2011

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