Salary Range: €57,900.00 - €107,500.00 Job Description Summary #LI-Onsite Location: Colleretto Giacosa (Ivrea), Italy This role is based in Ivrea, Italy. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. The Quality Assurance Operations Lead is responsible for ensuring the release of products manufactured in compliance with the Quality System, current registrations, and applicable regulatory standards. This includes guaranteeing that sterile injectable products meet GMP, FDA, AIFA, Novartis Quality Manual, and other relevant quality requirements, while ensuring site operations remain fully compliant. The position provides quality oversight of manufacturing activities, manages the human and technical resources of the Quality Assurance Operations department, and ensures effective QA support for the site’s commercial operations.
Job Description Deadline for applications: 18th of September 2026.
Major Accountabilities:

Lead the implementation and continuous improvement of compliance with applicable quality standards, including GMP, FDA, AIFA, the Novartis Quality Manual, and site quality procedures, while promoting a strong quality culture across the organization. Oversee QA Operations activities, including product release, documentation management, SOP approval, training, resource planning, shift organization for QPs and QA Officers, and professional development of team members. Ensure quality oversight of manufacturing operations, maintenance, qualification, calibration, revalidation, process validation, cleaning validation, equipment qualification, and new projects requiring QA Operations support. Manage and approve quality processes including OOS, OOT, OOE, deviations, change controls, CAPA, complaints, recalls, returns, investigations, and related corrective and preventive actions in accordance with cGMP and SOPs. Ensure timely escalation and communication of quality and cGMP issues, non-conformi

Quality Assurance Operations Lead

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