ATMP Quality Assurance Lead

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Summary

The ATMP QA is responsible for managing the ATMP QA Batch Preparation Hub team to oversee the preparation process for ATMP products, ensuring compliance with cGxP and Marketing Authorization Holders (MAHs). The QA Lead ensures that release preparation activities are performed timely and properly to meet customer satisfaction, and drives innovation and operational excellence projects to standardize and improve efficiency within the ATMP QA team and with stakeholders such as NCQ and Supply Chain Management.

About The Role

Major accountabilities :

• Support Qualified Person(s) in the field of ATMPs (both commercial and clinical preparations) and supervise clinical trainees according to licensing regulations.
• Compile and preliminarily review documents from databases.
• Execute batch record reviews of manufacturing documentation.
• Ensure compliance with GxP and legal regulations in the EU, and participate in GxP / SOP training.
• Communicate with national and international functions including CGT US, CGT CH, QA, supply chain, and responsible persons in various countries and depots.
• Archive documents related to clinical investigational medicinal products.
• Create and update SOPs.
• Evaluate pharmaceutical product complaints, deviations, and documentation.
• Prepare and maintain quality agreements.
• Maintain regular contact with Novartis manufacturing companies and third-party manufacturers.
• Participate in audits and inspections.
• Ensure efficient and innovative operation of the EU Release Preparation HUB team, driving productivity improvements and best practices.
• Degree in Pharmacy or related Healthcare field preferred.
• At least 5 years of experience in pharmaceutical manufacturing, QA, and QC; certification as an Advanced Therapy Medicinal Products (Cell & Gene Therapy) Qualified Person is preferable.
• Strong analytical thinking, flexibility, and problem-solving skills.
• Fluent in English, both written and spoken.

Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives. Learn more about our culture .

Join our Novartis Network : Not the right role for you? Sign up to our talent community to stay connected and learn about new opportunities : Join here .

Benefits and Rewards : Discover how we support your personal and professional growth : Benefits overview .

Additional Perks : Competitive salary, annual bonus, pension, share scheme, health insurance, 27 days' leave, flexible working, subsidized dining, employee recognition, learning opportunities.

Commitment to Diversity and Inclusion : We are dedicated to building an inclusive environment that reflects the communities we serve.

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