Quality Manager
Core
Own and improve the Quality Management System (QMS) for complex bioprocess equipment and automation systems, ensuring compliance with ISO 9001 and regulatory standards from development through customer delivery.
Role type
Quality Manager (Manufacturing & Systems)
Builds
Robust quality processes and compliant delivery of cell therapy manufacturing systems
Domain
Biotechnology / Cell Therapy Manufacturing / Automation Systems
Required skills
QMS management, ISO 9001 standards, supplier quality audits, non-conformance management, CAPA, regulatory compliance (GMP), stakeholder management
Preferred skills
Experience with complex equipment/automation, STEM degree, hands-on quality approach
Technologies
ISO 9001, GMP, QMS frameworks
Responsibilities
Maintain ISO 9001 certification, support quality across development/manufacturing/deployment, manage supplier quality audits, lead quality investigations and CAPA, embed quality processes across engineering and delivery teams, provide quality training and mentoring
Seniority
Mid-Senior, hands-on IC
