Quality Assurance Operations Expert – Biotechnology

About the role

DEMO SA is expanding its biotechnology footprint in Athens and seeks a senior Quality Assurance Operations Expert to provide independent QA oversight across manufacturing, QC/R&D, warehouse, and support activities.

Key responsibilities

• Provide independent QA oversight of biotechnology manufacturing, QC/R&D, warehouse, facility and support activities, ensuring compliance with EU GMP and the Pharmaceutical Quality System.
• Review and approve deviations, investigations, CAPAs, OOS/OOT events, change controls and effectiveness checks, ensuring proper root‑cause analysis and timely closure.
• Assess and approve qualification and validation strategies, protocols and reports for facilities, utilities, equipment, cleaning, processes, analytical methods and transport/storage activities.
• Lead inspection and audit readiness, coordinate documentation for regulatory inspections, internal audits and supplier audits, and manage follow‑up actions.
• Support supplier and material quality activities, quality risk management, metrics/trending and continuous improvement initiatives.

Required profile

• Bachelor’s degree in a relevant life‑science or engineering discipline; postgraduate degree is a plus.
• Minimum 7 years of experience in pharmaceutical or biotechnology industry with substantial GMP QA and/or operations exposure.
• Strong experience in biologics/biotechnology manufacturing, technology transfer, deviations, investigations, CAPA, change control and qualification/validation.
• Excellent knowledge of EU GMP requirements, pharmaceutical quality systems and biotechnology manufacturing processes.
• Ability to work independently, manage multiple priorities and exercise sound quality judgement.
• Very good command of English.

Required skills

• EU GMP compliance
• Pharmaceutical Quality System
• CAPA management
• Change Control
• Quality Risk Management
• Electronic quality, ERP and document management systems

What we offer

• Competitive remuneration
• Continuous learning and development opportunities
• Friendly and challenging working environment