PbJob Description Summary /b /p pCoordinating QC laboratory activities, responsible for ensuring compliance with cGxP and Novartis standards within the area of responsibility (during development, transfer, release, and stability), including safety testing, monitoring, and trending. Participating in the Pilot Plant build-up phase as a key team member for GMP quality control laboratories, as well as supporting development laboratories. /p pProvide guidance, support, and leadership for the implementation of analytical standards. /p pbKey Responsibilities: /b /p ol liEnsure quality, compliance, and efficiency in team operations while aligning with site strategies. /li liAct as the primary contact to address and manage laboratory issues related to equipment, analysis, compliance, and operational challenges. /li liPlan and coordinate lab activities, ensuring the timely release of materials and products, proper inventory management, and adherence to site lead times. /li liCreate capacity plans to meet business objectives, optimize laboratory performance, and proactively ensure team compliance with HSE and operational procedures. /li liOversee analytical activities, including data review, batch release, analytical method lifecycle (validation, transfer, troubleshooting), and stability studies in collaboration with the Analytical Development Team. /li liMaintain inspection readiness, supervise compliance with cGxP, GLPs, ALCOA+ principles, and manage deviations, CAPAs, and Change Controls as required. /li liLead and develop team members by monitoring training compliance, ensuring qualifications for GMP tasks, fostering a culture of engagement and accountability, and supporting talent development. /li liPromote a positive and motivated work environment by providing constructive feedback, coaching, and modeling cultural aspirations aligned with company values. /li /ol pbEssential requirements: /b /p ol liMaster’s degree (preferred) or equivalent in Pharmacy, Chemistry, or a similar scientific field. /li li5+ years of experience in a similar role within a GMP-regulated laboratory environment. /li liStrong background in analytical laboratory operations and quality management systems, with knowledge of Good Documentation Practices and Data Integrity principles. /li liExperience in the nuclear medicine industry (preferred). /li liHighly organized, detail-oriented, and accuracy-focused with the ability to work independently as a self-starter. /li liProven personal ethics, responsibility, and dedication to purpose. /li liExcellent written and verbal communication skills, including experience interacting professionally with external vendors or business partners. /li liStrong familiarity with GMP compliance and laboratory workflows. /li /ol pbWhy Novartis? /b /p pOur purpose is to reimagine medicine to improve and extend people’s lives, and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates who drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: /p pbYou will receive: /b You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook: /p pbCommitment to Diversity and Inclusion: /b Novartis is committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities we serve. /p pbJoin our Novartis Network: /b 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: /p pbSkills Desired: /b Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (EHS), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, SOP (Standard Operating Procedure), Technical Writing, Waterfall Model /p #J-18808-Ljbffr