Petra Štěpánková, BSc, MRQA
Global Head of Quality Assurance, AICROS Head of Quality Assurance, GCPService International Certified ISO 9001 Lead Auditor by BSI Petra Štěpánková is an accomplished Quality Assurance leader with extensive experience in global pharmaceutical, biotechnology, and medical device clinical research. With a proven track record of driving quality excellence, regulatory compliance, and organizational harmonization, she plays a key role in ensuring clinical trials meet the highest international standards. Petra has prepared numerous sponsors, CROs, and investigational sites for FDA and European regulatory authority inspections. Her experience includes leading inspection teams, conducting pre- and post-inspection training, managing follow-up activities, and supporting the resolution of audit findings. Welcoming challenges and maintaining a structured, pragmatic approach to problem-solving, her expertise spans a wide spectrum of QA activities, including system, vendor, electronic tools, laboratory, and investigator site audits—performed predominantly worldwide. She has successfully passed numerous sponsor audits and conducted audits for global pharmaceutical and medical device companies. Petra is highly experienced in root-cause analysis, CAPA design and oversight, QA trend analysis, and the development and continuous improvement of internal Quality Management Systems (QMS). As a certified ISO 9001 Lead Auditor (CQI/IRCA, BSI Training Academy), she performs ISO 9001, ISO 14155, and ISO 13485 audits and provides QMS consultancy support across organizational teams. She successfully coordinated international QMS harmonization initiatives during mergers involving midsize CROs and large pharmaceutical companies. She has also supported healthcare institutions, pharmaceutical companies, CROs, and other organizations in building and enhancing QMS frameworks to meet regulatory requirements. Petra also serves as a trainer in specialized QA and Good Clinical Practice (GCP) topics. As Global Head of Quality Assurance at AICROS, Petra provides strategic quality leadership across multiple international CRO partners. She strengthens operational alignment, assures regulatory compliance, and supports high-quality delivery in multinational clinical trials. Since 2017, Petra has led the international AICROS QA team, driving continuous improvement initiatives and fostering a culture of excellence.