Summary Role Purpose: Responsible for ensuring compliance with cGxP and Novartis standards for the assigned topics during development, transfer, release, and stability, including safety testing, monitoring, and trending. Participates in the Pilot Plant build-up phase as the qualification responsible for GMP quality control labs and supports development labs. Provides guidance, support, and leadership for the implementation of analytical standards. About The Role Key Responsibilities: Lead projects for initial qualification of laboratories, analytical instruments, and systems; approve qualification documents where applicable. Plan qualification activities based on business needs. Ensure readiness and release of instruments accordingly. Maintain qualification and calibration status of analytical equipment, utilities, and facilities (including alarm management and pest control). Manage Change Control: initiate and own change requests related to laboratory implementation; initiate, own, and approve CAPA and Task Loop. Author and review SOPs within the area of responsibility. Ensure laboratories are maintained according to cGxP standards and compliant with regulatory requirements and guidelines. Prepare and maintain inspection readiness; contribute to GxP audits/inspections; keep methods and procedures up-to-date. Manage documentation and methods in accordance with cGxP. Manage external service providers and instrument vendors involved in laboratory qualification processes. Leadership & Culture Support training initiatives by identifying and reviewing relevant training for all in-scope associates. Ensure associates are qualified for GMP tasks prior to independent performance. Monitor training compliance among in-scope associates. Identify and maintain a list of subject matter experts in relevant areas. Create a work environment that fosters high employee engagement. Model the culture of being Curious, Inspired, and Unbossed; ensure alignment and accountability among leaders and associates. Ideal Background Education Master's degree in Pharmacy, Chemistry, Engineering (chemistry, physics, or similar scientific field) preferred. Languages Proficient or native Italian speaker. Fluent in English, both written and spoken. Experience / Professional Requirements At least 2 years' experience in a similar GMP role. Experience with quality management systems. Analytical laboratory experience in a GMP environment. Knowledge of the nuclear medicine industry is a plus. Highly organized, detail-oriented, with a strong focus on accuracy. Knowledge of Good Documentation Practices and Data Integrity principles. Strong personal ethics and responsibility. Ability to work independently and proactively. Excellent communication skills, including experience liaising with external vendors and partners. Why Novartis: Helping people with disease and their families requires more than innovative science. It takes a community of passionate, collaborative individuals like you. Join us to make breakthroughs that change lives. Learn more. Join our Novartis Network: Not the right role? Sign up to our talent community to stay connected and discover future opportunities: https://talentnetwork.novartis.com/network. Benefits and Rewards: Discover how we support your growth and well-being in our handbook. J-18808-Ljbffr