Adelheid Schweiger-Schütz

About

Senior pharmaceutical quality executive with over two decades of experience in GMP-regulated environments, specializing in Quality Management, regulatory compliance, and organizational transformation. Currently serving as Head of Quality Management at Loba biotech GmbH, focusing on enhancing Quality Systems, ensuring regulatory readiness, and fostering operational excellence. Demonstrated expertise in Transformation, Corporate Strategy, and Teammanagement, with a strong commitment to driving quality initiatives and compliance in the pharmaceutical and biologics industries. Dedicated to building high-performing teams and establishing sustainable quality practices.

Experience

• Head of Quality Management at Loba biotech GmbH
  Dec 2024 - Present · 1 yr 7 mos

• Sanochemia Pharmazeutika (Neufeld an der Leitha, Burgenland, Austria)
  • Director Quality Assurance & Pharmacovigilance / QMR
    Apr 2022 - Dec 2024 · 2 yrs 9 mos

    Responsible and accountable for Quality Systems, Quality in Operations, Supplier Quality, Regulatory Compliance, Audit Management, Produkt Release and Pharmacovigilance

  • Head of Quality Assurance/ QMR
    May 2020 - Apr 2022 · 2 yrs

    Building a new QA Team, responsible and accountable for Quality Systems, Quality in Operations, Supplier Quality, Regulatory Compliance, Audit Management, Produkt Release

• Sanochemia Pharmazeutika AG (SAC) (1 yr 4 mos)
  • Head of Quality Assurance/ FQMR
    Oct 2019 - May 2020 · 8 mos

    Implementation of a new, improved QMS to get the full GMP Certificate back (April 2020 - full GMP Certificate), responsible & accountable for QMS, Quality Systems, Quality in Operations, Product Release, Audits/ Auditmanagement, Supplier Qualification

  • Head Of Quality Assurance
    Feb 2019 - Oct 2019 · 9 mos

    Implementation of a new, improved QMS to get the full GMP Certificate back, responsible for Quality Systems, Quality in Operations, Supplier Quality, Regulatory Compliance, Audit Management, Produkt Release

• Senior Consultant at Arcondis Group
  Oct 2014 - Jan 2019 · 4 yrs 4 mos

  Succsessful implemented Projects: Implementation of an eQMS/ Improvement of the QMS Relocation of GMP/Release laboratory Implementation of "Annex 16 - relocation of testing site" (Pharma) Implementation "GDP for APIs" (Pharma) RSPO Certification of a Palmoil (Food) Implementation of TrackWise for Complaint Management (MedTech) Implementation of Change Control Management Process for Computerized Systems(MedTech) IT Compliance Audit (MedTech) GMP and ISO9001 Compliance (Pharma Supplier)

• Baxter AG (12 yrs 9 mos)
  • Senior Quality Specialist
    Aug 2012 - Sep 2014 · 2 yrs 2 mos

    System Owner Change Control Implementation of TrackWise for Change Control Management Development and Improvement of Change Control Process

  • Senior Manufacturing Specialist
    Jun 2008 - Jul 2012 · 4 yrs 2 mos

    Teamleader of GMP Support Team, process management, GMP and compliance support, trainings and documents responsibility, internal auditor

  • Quality Product Owner
    Jul 2004 - May 2008 · 3 yrs 11 mos

    QPO for biological surgery products and sugery medical devices, responsible for stability studies, specifications and the quality part of submissions world wide, global project core team member for development and submission projects