EXTEDO
Birgit Doblhofer has extensive work experience in quality management and processes. Birgit currently holds the role of VP Quality & Processes / Quality Management Officer at EXTEDO, a position they have held since January 2020. Prior to this, they served as the Director Quality & Processes / Quality Management Officer at the same company from April 2017 to December 2019. Before joining EXTEDO, Birgit worked as a Validation Manager / Quality Manager at the company from June 2016 to March 2017.
From 2009 to 2016, Birgit worked at a Management Consulting firm as an EOQ Auditor / EOQ Quality System Manager. Prior to that, they held various roles at IDEA AG, including Head of Quality Assurance from April 2002 to May 2009 and Manager Quality Assurance from October 2000 to March 2002. Birgit also worked as a Senior Technician (CTA) from September 1998 to September 2000 at IDEA AG.
Birgit began their career as a Technician (CTA) at Chemisches Untersuchungslaboratorium Dr. Böhm from October 1990 to August 1998.
Birgit Doblhofer has a diverse education history. In 1988-1990, they attended Chemieschule Dr. E. Elhardt, where they obtained a degree in Chemical Technical Assisstant, specializing in Food Chemistry / Instrumental Analytic. Subsequently, in 2001-2002, they pursued further education at Deutsche Gesellschaft für Qualität and acquired degrees in EOQ Quality Auditor (in EN ISO 9001:2015) and EOQ Quality System Manager (in Quality Management). In 2018, they attended Deutsche Gesellschaft für Qualität and completed a degree in DGQ Data Protection Officer. Lastly, in 2021, they participated in a program at Deutsche Gesellschaft für Qualität and became a Quality Representative Medical Device.
EXTEDO
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and provide solutions covering the entire regulatory landscape: Document Management Planning & Tracking Product Registration (XEVMPD & IDMP) Submission Management (eCTD, RPS, CTD, NeeS, IMPD, CTA, eCopy, DMF, ASMF, VNeeS, CADDY, ePRISM, eIndex) Pharmacovigilance Management and Drug Safety (SUSAR, ICSR, PSUR, DSUR, E2B, MedDRA, SMQ, GVP, CIOMS, MedWatch, R3) Today, EXTEDO enables around 35 regulatory authorities and 1000 maintained customers across 65 countries to deliver Effortless Compliance™. Our clients range from small CROs to large multi-national pharmaceutical organizations, and we cover industries from biotech to homeopathics, and medical devices to crop sciences. Our mission of Effortless Compliance™ ensures that organizations are able to spend more time doing the things they want to do, rather than the things they have to do. For more information visit www.extedo.com.