Dorte Larsen

Experience

• 

  VersaMatrix

  Jan 2003 - Jan 2007

  Chemist

  Development of Encoded Bead technology (High Throughput screening method)Funtionalisation of resin incl. upscalingResin synthesisPeptide synthesisQuality control of resin.

• 

  Novo Nordisk A/S

  Mar 2007 - Apr 2010

  Chemist

  In charge of development of Encoded Bead technology (High Throughput screening method) - instrument and resin.A crossfunctional project including software and hardware developers as well as manufacturers of custom made parts for the instrument.

• 

  Novo Nordisk Pharmatech A/S

  May 2010 - Sept 2015

  IT Project Manager

  Project management of systems and infrastructure implementation under GXP regulatory requirements. Projects include:-SAP implementation (Finance, warehouse, logistics, production, sales, production planning) -Infrastructure upgrade of administrative and production servers and alignment to corporate standards-Network domain migrations-Win7 Roll out

• 

  Novo Nordisk

  Oct 2015 - Jun 2018

  IT Project Manager

  Project management of IT projects for new production site established from greenfield (AP Expansion) Projects include:-SAP project (finance, production, warehouse, production planning)-Network implementations for BMS, production and administrative networks-Implementation of system management setup for local GXP systems-Assessment of electronic records and electronic signatures

• 

  Radiometer

  Jul 2018 - now

  PMO and team management and global CAPA Process owner Manager of 17 reports incl. two team leaders. 1 team located in Poland the other in Copenhagen. Process owner of the Customer Complaint and CAPA processes. Position covered both daily operation but also improvements and projects including implementation of a customer complaint IT system. Driving high level requirement mapping and vendor search for IT system to cover nonconformance and CAPA processes. Process owner of the CAPA process and managing a small team of CAPA coordinators. Was additionally interrim manager for QA operations team for 6 months. Project manager of Global roll out of solution and process for change control to 7 sites.

  • Senior Manager RA/QA Projects and CAPA

    Dec 2023 - now

  • Senior Manager of Complaint handling and CAPA

    May 2022 - Nov 2023

  • Senior Manager QA Global projects and CAPA

    Jun 2021 - May 2022

  • Senior Project Manager

    Jul 2018 - May 2021