Job Description

28,000 associates of more than 100 nationalities deliver high quality and affordable medicine on time, every time, safely and efficiently. Your key responsibilities: Your responsibilities include, but not limited to: . Provide Leadership & manage Quality Assurance Managers in all quality related matters and to ensure that all aspects of the operational business comply with cGMP (Current Good manufacturing Practices) legal and regulatory requirements and the Novartis Quality Manual & Policies. . Ensure that all products manufactured by site/External Supplier in addition to the imported products for local site are released to the market according to Novartis Quality Standards. . Oversight of Quality Operations across site. Inbound QA Oversight. Outbound QA Oversight. MBR review and approval. Product release. QA for Quality Control and AS and T. QA Operational Excellence. Initiate and drive local hiring process. Line responsibility and daily walkthrough. . Lead OpEx Projects. Investigation of Deviation, OOx, Complaints. Define and implement CAPAs. Support transfer Projects & validation studies. Track team metrics and ensure KQI /KPI meet requirements. Review and approve text and design. HSE incidents reporting and action follow up. . New equipment commissioning Support (OQ, PQ). Define improvement areas in process and products. Resource and capacity (people and equipment) planning and workload management. . Performance and leadership Support to specialist team. Ensure availability of equipment, chemicals and consumables, AS appropriate. SOP review and revision. Perform local training and monitor training status. . Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt. Distribution of marketing samples (where applicable). Diversity & Inclusion / EEO Minimum Requirements What you\'ll bring to the role: . Preferred Qualification- M. Pharma with minimum 10 years of experience in Manufacturing Quality/Compliance. Experience in Large molecules handling/Aseptic processing is preferred. . 10 years of experience in in the pharmaceutical industry. Min 8 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical processes and manufacturing of biologics. . Min 10 years of experience in operational quality assurance. Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities. Expert in risk management. Advanced understanding of project management. . Expert in communication and advanced negations skills. Advanced decision-making skills. #Transformingforgrowth Why Novartis 236 million lives were touched by Novartis medicines in 2022, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking 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! Accessibility and accommodation Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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