Kvaliteedijuht

We are seeking an experienced Quality Assurance (QA) Manager to lead and oversee the maintenance, and continuous improvement of Cellin’s QMS in compliance with EU GMP standards for ATMPs. The ideal candidate will have a strong background in quality assurance for cell or gene therapies, with hands-on experience in GMP environments.

This role requires a proactive, detail-oriented professional who can manage QA operations and drive quality culture across the organization. You will work closely with manufacturing, regulatory, and R&D teams to ensure compliance and product quality throughout the development and production lifecycle.

• Lead the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with EU GMP regulations for ATMPs.
• Oversee QA operations, including batch record review, deviation and CAPA management, change control, supplier qualification, and document control.
• Ensure quality oversight of manufacturing and testing activities, including aseptic processing and cleanroom operations.
• Support regulatory inspections, internal audits, and external audits of suppliers and service providers.
• Provide QA input for tech transfer, validation, and qualification activities (equipment, utilities, processes).
• Collaborate with cross-functional teams to ensure product quality from development to release.
• Drive continuous improvement initiatives across quality systems and processes.
• Maintain up-to-date knowledge of regulatory requirements relevant to ATMPs, GMP, and GxP.