Blog

Brian DiVasta

Brian DiVasta is Director for Computer System Validation for elevatebio for 3+ years. There his specialities are computer validation and quality assurance. Before his position at elevatebio he was with Sanofi for 8+ years as Associate Director, ITS Compliance.Read more

Peter Hackel

Since October 2023 he is Head of Data, Digital and Technology at Takeda Vienna. Before that he was responsible for the implementation of a manufacturing intelligence solution in Europe and Asia at Shire and prior to that responsible for the implementation and setup of a manufacturing intelligence solution in Europe and Asia. at Baxter.Read more

Esra Guven

Results-driven and accomplished professional with over 23 years of expertise in Computer Systems Validation (CSV) and Quality Assurance (QA). Proven track record in orchestrating GxP systems, ensuring regulatory compliance, and driving continuous improvement initiatives. Adept at leading high-performing teams, implementing Agile Methodology, and successfully presenting and defending systems validation during regulatory audits.Read more

Kerstin Voss

Kerstin Voss is responsible for global manufacturing processes and IT support in Bayer Pharmaceuticals. Throughout her career, she has specialized in MES and Historian and demonstrated in addition leadership in positions in supply chain and quality assurance. She draws on her extensive experience in transport compliance and the quality department of a supply center inRead more

Gabriel Gimenes

Electrical Engineer with 18+ years of experience, 15 of which were dedicated to the pharmaceutical industry. Working in areas such Maintenance, Project Management, Automation, Utilities, Engineering Compliance, Equipment Qualification, and Asset Life Cycle Management. Currently leading Engineering and HSE at the Cambé site. (Moving to Les Franqueses – Spain site for a decommissioning project) TheRead more

Shannon Ostendorff

Shannon Ostendorff leads the Lonza Asset Management Program as Head of Global Maintenance Excellence at Lonza. Based out of Bend, Oregon (USA), she leads an integrated global program which realizes value from assets by optimizing maintenance and calibration processes , reducing downtime to maximize utilization and optimizing lifecycle cost of assets. Shannon has over 20Read more

Ulrike Falk

Ulrike Falks is Quality Head for all BioPharma Sites of Boehringer-Ingelheim in Europe, USA and China; Drug Substance and Drug Product; CMB and internal products as well as Combination Products; Launch and Innovation Quality, 3Party Quality Management and Quality Systems are also part of the network, embracing around 2000 colleagues worldwideRead more

Geoffrey Pot

Motivated, innovative, agile, and collaborative executive leader in a top 10 Biotech / Pharmaceutical company with more than 15 years of experience, managing large manufacturing plants and multi-faceted global teams across manufacturing facilities in Asia, Europe and United States. Geoffrey is passionate by digitalization/digitization and innovation, and firm believer there is more power in “we”Read more

Sam Laermans

Sam, originally from Belgium and currently residing in Marburg, Germany, graduated as an Engineer with an additional Master’s degree in General Management from Vlerick Business School. Throughout his career, he has been involved in the Life Science industry, focusing on large-scale digital transformation projects. These projects included significant mergers and acquisitions. Following his consulting work,Read more

Martin Kavanagh

Accomplished Manager and consultant with over 23 years working in manufacturing IT, mainly focused on Manufacture Execution Systems (MES) Manufacture Operations Management (MOM), within the regulated industries. Experienced at managing and leading programsprojects from concept, design, implementation, qualification and right through to operational running, and delivering systems at both site and enterprise level.Read more