Analytical Manager in External Supply Organization

Key Responsibilities

• Lead implementation and continuous improvement of the ESO AS&T quality system, tools, and analytical processes
• Drive global AS&T programs and ensure compliance with internal standards, regulatory expectations, and data integrity requirements
• Responsible for managing analytical changes and providing required assessments during general change control activities. Defines and oversees studies and evaluations necessary to support analytics-related changes
• Own and maintain testing monographs, ensuring alignment with registrations, pharmacopeia standards, and state-of-the-art methods
• Responsible for leading analytical transfer assessments and the implementation of new analytical methods
• Lead and support ESO stability programs at external manufacturers, ensuring regulatory compliance and scientific robustness.  Interpret stability data, analyze trends, and define corrective actions addressing emerging stability or analytical issues
• Manage and escalate analytical investigations, ensuring effective root cause analysis and implementation of appropriate CAPAs
• Act as single point of contact for analytical topics in cross-functional ESO AS&T projects and external collaborations
• Support supplier qualification, audits, Health Authorities response and inspection readiness, providing expert analytical input as required

Essential Requirements:

• University degree in pharmaceutical sciences, chemistry, or another relevant natural science discipline
• At least five years of professional experience, primarily in quality control within a regulated environment
• Strong knowledge of analytical quality systems, stability programs, and analytical change management principles
• Proven experience managing analytical investigations in compliance with current Good Practice standards
• Ability to interpret complex analytical and stability data and draw scientifically sound conclusions
• Fluency in written and spoken English, with the ability to communicate effectively across functions and cultures

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. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:  Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.