Resumen
About the Role
Major accountabilities:
- Execute the TRD digital capability validation strategy, providing guidance and hands-on operational support to TRD teams.
- Collaborate with Data & Digital, IT, Business, Quality and external service providers to ensure consistent validation standards globally.
- Own and maintain the validation master plan, ensuring timely execution and inspection readiness.
- Establish, monitor and improve TRD digital capability validation performance metrics to support compliance and operational excellence.
- Provide technical leadership for validation risk assessments, investigations, and complex validation challenges.
- Perform risk and impact assessments and define appropriate validation approaches based on system criticality and regulatory principles.
- Support new system implementations, system changes and the ongoing compliant operation of validated applications.
- Ensure data integrity and regulatory compliance throughout the system lifecycle.
- Represent the TRD organization during audits, inspections, and validation governance activities while maintaining compliance standards.
- Driving continuous improvement initiatives to enhance validation effectiveness, compliance, and operational performance.
- Reviewing validation protocols, reports, risk assessments, and related technical documentation.
Essential Requirement:
- Master’s or bachelor’s degree in chemistry, Pharmacy, Chemical Engineering, Computer Science, Biological Sciences, Pharmaceutical Technology, or a related scientific discipline.
- 10+ years of relevant experience in quality assurance and computer system validation, with at least 2 years in Pharma/Healthcare. Cross-industry experience highly preferred. 2+ years of international experience working with Global teams.
- Strong knowledge of quality systems and global regulatory requirements across multiple health authorities.
- Knowledge of pharmaceutical and/or life sciences domain is an advantage
- Experience working in a matrix environment with cross-functional stakeholders is desirable
- Excellent communication, negotiation, facilitation, and interpersonal skills.
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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
