Quality Systems Lead

The Quality System Lead Support GxP compliance of ADACAP commercial products applicable for the site, in accordance with internal procedures and processes as well as Health Authorities regulations. In collaboration with the site Quality team, contribute to the appropriate oversight, assessment and mitigation of risk to quality practices, processes and systems to ensure that all aspects are in compliance. Your key responsibilities: Your responsibilities include, but are not limited to: • Provides oversight for the implementation of Quality Systems which include Non conformances, CAPAs, Effectiveness Checks, Change Controls, Training, Inspections and Audit readiness, Technical complaints, Risk Assessments and remediation, Annual Product Quality review, self-assessments, KPIs and Quality Management Review. • Support strategic site quality system and works in collaboration with Manufacturing Operations to review the compliance of written procedures to GxP, including but not limited to monitoring and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations. • Support the audit and inspection management, inspection strategies, preparation, interactions and responses and supports complaints management. • Support the preparation of the annual site Quality Plan and supervise the closure of associated actions. • Issue the annual self-inspection program, oversight its management and execution, and tracking/closure of associated CAPAs. • Collaborate with site Senior Data Integrity Manager, DI Champions and DI SPOCs on their local departments DI actions and related DI challenges and issues to drive behavioral change management activities to strengthen DI culture. 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: • 5 or more years’ experience in the pharmaceutical industry with direct experience knowledge of quality system (GMP) with Compliance and Quality Systems • Experience in drug development, clinical, manufacturing, outsourcing and/or other relevant operational areas which must include at a minimum 5 years in QA • Thorough knowledge of GCP, GMP and PV requirements • Strong understanding of regulatory Quality Systems requirements Work location: Colleretto Giacosa. 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