Job Description

Summary

The IT/CSV Business Analyst will ensure end-to-end traceability and compliance for GxP-relevant systems in a regulated pharmaceutical environment. This role combines rigorous validation practices with advanced data proficiency to optimize processes and support decision-making, while maintaining alignment with Security, Quality, and IT governance frameworks.

About the Role

Major Accountabilities:

Create and maintain traceability between user requirements, functional/technical specifications, test cases, and validation evidence for GxP systems. Lead and support test planning and execution, including risk-based test design, defect management, and objective exit criteria. Ensure strict adherence to Security, Compliance, and Quality policies (GxP, data integrity, access management) and documentation standards within Service Delivery. Maintain controlled documentation: URS/FRS/DS, test protocols/reports, validation plans/reports, SOPs/WIs, and change/control records aligned to DDIT governance and TT Service Portfolio. Apply industry best practices and reusable platforms/templates; minimize customization in favour of configuration for COTS solutions. Analyse and improve local business processes using advanced data analysis and digital tools to increase reliability and throughput. Engage business representatives and partner with DDIT teams to elicit, refine, and manage requirements; translate business needs into implementable, testable specifications. Ensure audit readiness: maintain complete, current validation packages; address findings and CAPAs promptly. Define test strategy per system risk classification (GxP impact, data integrity, cybersecurity). Author and review test scenarios, scripts, expected results, and acceptance criteria mapped to requirements. Orchestrate UAT: environment readiness, data sets, role-based testers, defect logging, and closure. Assure test evidence quality and traceability in the validation repository. Automate regression were feasible; maintain reusable test libraries for configured COTS.

Minimum Requirements:

Experience in regulated pharmaceutical environments with GMP/QA/validation exposure. Demonstrated ability to structure regulatory and quality information using digital tools and data. Proven record of influencing without authority and managing relationships across departments and locations. Experience interacting with senior stakeholders in quality, operations, and IT, including workshops and reviews. Multi-national and cross-functional collaboration. Advanced data proficiency; ability to leverage digital tools for data analysis, process optimization, and decision support. Analytical thinking; structured problem solving under compliance constraints. Concise, evidence-based communication and audit-ready documentation. Requirements analysis and requirements gathering. Test design and validation documentation per GxP and security standards. Proficiency with Microsoft 365 toolset for documentation, tracking, and reporting. Degree in Pharmacy or related life-science discipline (or equivalent). Fluent German & English.

Preferred:

Experience in pharmacy operations with workflow optimization. R&D Quality Assurance internship/placement with deviation/trending and cross-site coordination.

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.

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to inclusion.switzerland@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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

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



Division
Operations
Business Unit
Universal Hierarchy Node
Location
Switzerland
Site
Stein Aargau
Company / Legal Entity
C046 (FCRS = CH046) Novartis Pharma Stein AG
Functional Area
Technology Transformation
Job Type
Full time
Employment Type
Temporary (Fixed Term)
Shift Work
No