Erik Sommer, PhD

Head of Global Quality Systems/Deputy RP for GDP

Mannheim, Baden-Württemberg, Germany

About

For patients! Committed and motivated quality professional and leader with broad expertise in all areas of quality systems, quality management, quality operations, and quality assurance for sterile (implantable) medical devices and pharmaceuticals. Very strong analytical mind and communicator who loves to break down and transfer complex topics and solve complex problems. Focus on possibilities for digitalization and use of artificial intelligence in quality and beyond.

Experience

  • Head of Global Quality Systems/Deputy RP for GDP at Wörwag Pharma GmbH & Co. KG
    Jan 2024 - Nov 2024 · 11 mos

    Quality Management Systems, Lead Auditor, Project management, Line management, KPI, Complaint Management, Pharmacovigilance, CAPA, Deviation management, Change management, CSV, Service provider management, EU-GMP, EU-GDP

  • Senior QA Manager EMEA/Quality Management Representative/PRRC Authorized Representative at HOYA Surgical Optics
    Sep 2021 - Dec 2023 · 2 yrs 4 mos

    Distribution Quality, Supplier Quality Management, Person Responsible for Regulatory Compliance for EU-Authorized Representative, Quality Management Systems, Lead Auditor, Project management, Line management, MDR, ISO 13485, ISO 14155, ISO 14971, CAPA, Management Review, KPI, Complaint Management, Vigilance

  • Fresenius Medical Care ()
    • Head of Quality Systems
      Oct 2014 - Aug 2021 · 6 yrs 11 mos

      Deputy of Director Quality Operations, Quality Management Systems, Corporate Lead Auditor, Project management, Line management, ISO 13485, 21 CFR 820, ISO 14971, GMP, cGMP, CAPA, Management Review, KPI, Change Control, Risk management, FMEA, Validation, Qualification, ISO 15378, GMP Packaging

    • Project Coordinator Microbiology
      Nov 2013 - Sep 2014 · 11 mos

      Projectmanagement, LIMS, assay automation, processanalysis and -optimization, Biostoffverordnung

  • ZMBH, University of Heidelberg ()
    • Research scientist (Postdoc)
      Feb 2012 - Jun 2013 · 1 yr 5 mos

      Research on microbial protein networks and development and optimiza- tion of new fluorescence microscopy techniques for protein-protein interaction screenings

    • PhD student
      Dec 2007 - Feb 2012 · 4 yrs 3 mos

      Research on microbial protein networks using molecular genetics and fluorescence microscopy