QA Operations Lead

The QA Operations Lead provides strategic and technical leadership to the belonging quality unit, in collaboration with the Site Manager, the Quality Site Head, the Quality Control Responsible and the Production Responsible for the site objective and for assuring the business continuity. Your key responsibilities: Your responsibilities include, but are not limited to: • Guarantee and perform the release of products, in accordance with the procedures laid down in the Quality System and according to the current registrations. • Ensure that the quality of products conforms with the quality standards applicable to the manufacture of sterile solution for injections products laid down by the GMP, FDA, AIFA, Novartis Quality Manual and/or any other applicable procedure or standard. • Guarantee that the site operates according to applicable quality standards: FDA, GMP, AIFA, Novartis Quality Manual, and/or any other applicable procedure or standard. • Ensure appropriate supervision of manufacturing operations. • Manage the human and technical resources of the Quality Assurance Operations department. • Ensure the right level of support from QA perspective to the commercial operations of the site. • Participate to the annual training plan definition, the annual self inspection plan, the annual PQR review. • Management of complaints, product recall, change controls. • Manage the resources in his charge to ensure that the tasks under his responsibility are carried out with the maximum effectiveness. Promote the professional development of collaborators in his area of responsibility (Talent management). • Ensure the appropriate level of supervision in new projects requiring the participation of Quality Assurance Operations. Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. What you’ll bring to the role: • Scientific Master Degree. • At least 5 years’ experience in a similar role within the pharmaceutical industry. • Strong affinity with and awareness of quality issues, QA Operations. • Appropriate sense of urgency around given tasks, work in team. • Fluent in English and Italian. • Qualified Person qualification released by AIFA will be considered as a strong plus. Why Advanced Accelerator Applications? Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine? We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis Imagine what you could do at Novartis Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network J-18808-Ljbffr