Μαίρη Κουστέρη

Senior Quality Assurance and Compliance executive with 20+ years of experience across pharmaceutical manufacturing, APIs and medical devices. Proven track record in building and leading integrated quality management systems (IQMS), ensuring GMP/GLP/GDP compliance, and successfully managing global regulatory inspections and audits. Strong leader with extensive experience in external manufacturing oversight, risk management, CAPA, validation, and supplier quality. Adept at partnering with global stakeholders and executive leadership to drive a culture of quality, compliance, and continuous improvement.
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CORE COMPETENCIES
• GMP, GLP, GDP Compliance (EU, FDA, International)
• Integrated Quality Management Systems (IQMS)
• Regulatory Inspections & Audit Readiness
• CAPA, Deviations & Change Control
• Risk Management (ICH Q9)
• Supplier & External Manufacturer Quality
• Validation & Qualification (VMP)
• Quality Leadership & Team Development
• Complaint Handling & Product Quality Reviews