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.

Deadline for applications: 18th of September 2026. 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-conformities, product-impacting incidents,



and substantial irregularities involving products already placed on the market, including communication to relevant internal stakeholders and competent authorities when required.

Support audits, inspections, and quality reviews by participating in authority and corporate audits, annual self-inspection planning, annual training planning, and Annual Product Quality Review preparation and review. Monitor, report, and drive quality performance by tracking assigned indicators, ensuring projects and responsibilities are completed on time, and supporting business continuity in collaboration with Site Management, Quality, Quality Control, and Production leaders. Provide QA support to commercial operations while ensuring compliance with environmental, safety, order, cleanliness, internal communication, and external communication requirements within the area of responsibility.

Scientific degree in Pharmacy, Chemistry, or Biology. ~5+ years of experience in the pharmaceutical industry, with strong knowledge of QA Operations and quality requirements. ~ Solid knowledge of aseptic processes and aseptic manufacturing practices. ~ Strong communication and collaboration skills, with the ability to support smooth and safe production operations, drive productivity improvements through new technologies and processes. ~ Fluent in Italian and English, both written and spoken.

Experience in a high-tech production environment as a Qualified Person is highly valued.



At Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen. The rewards of being part of our team go far beyond base pay and incentives.We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs.

In addition, we provide flexible and hybrid working options, where possible, and a minimum of 14 weeks paid parental leave. The salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically. In addition to your base salary, you may be eligible for a performance-based premio depending on certain performance parameters.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve. Helping people with disease and their families takes more than innovative science. Collaborating, supporting and inspiring each other.

Benefits and Rewards Helping people with disease and their families takes more than innovative science. Collaborating, supporting and inspiring each other.

Benefits and Rewards

📌 Quality Assurance Operations Lead (Ivrea)
🏢 Novartis Italia
📍 Ivrea