Desiree Gruber

Experience

• 

  Dr. Rahimzadeh – Ingenieurbüro für Chemie

  Oct 2010 - Mar 2011

  Scientific Employee
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  University of Graz

  Oct 2013 - Mar 2014

  Contributing Lecturer
• 

  Sandoz

  May 2015 - Jul 2019

  Process Manager

  Overall plant and production responsibilityProfessional leadership of around 30 production employeesCoordination of audits, process transfers, process upscaling, QRAs, qualification, validation and production improvements Budget planning and staff deploymentComplex deviation handling and change managementEnsuring of deliveries, HSE and GMP targets

• 

  Novartis

  Aug 2019 - now

  Responsible for the end-to-end product quality stewardship of assigned Novartis biologics across multiple sites (or platforms, DS and DP sites, including CMOs) throughout the product lifecycle, from late phase development to discontinuation. Lead and management of a team of QA professionals managing external suppliers (ad interim). Responsible for managing quality aspects at external suppliers for Pharmaceuticals and Devices to ensure that the operational business is in compliance with cGMP, the Quality Assurance Agreement, regulatory requirements and the Novartis Pharma Quality Manual. Lead and management of analytical development activities within global cross-functional teams and networks (early and late phase development)Global third party and complex international and multidisciplinary stakeholder managementResource and budget planning, timeline and forecast monitoringMentoring, lead and support in deviation/OOS handling and change management optimization Lead and optimization of activities in assigned projects and networksGlobal development, monitoring and reporting of KPIs Lead and contribution to quality compliance activities on a global levelMentoring, lead and support in deviation handling and change management optimizationSupport of Pilot Plant manufacturing processes

  • Global Product Quality Lead

    Jan 2024 - now

  • ESO QA Lead

    Oct 2023 - Dec 2023

  • QA Manager ESO IM SM

    Apr 2022 - Dec 2023

  • Analytical Project Lead (Associate Director Science & Technology) - ARD (GDD TRD)

    May 2020 - Apr 2022

  • Drug Product Project Lead (Senior Fellow) - PHAD (GDD TRD)

    Aug 2019 - Jul 2020