Summary
About the Role
Quality Manager - TRD
About the Role:
Provide quality assurance with minimum experience on handling IT systems to provide guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.
Key Responsibilities:
- TRD QA Manager as Business System Owner for IT application is responsible for overall development, maintenance, integration, operation of GXP validated system.
- Plays vital role in system enhancements to ensure operational requirements are documented, tested and implemented as per IT Waterfall Methodology.
- Acts as a single point of responsibility for application for ensuring the system and data are secured as required by Information Security and Compliance requirements.
- Is responsible to identify IT system upgrades to enhance system performance and mitigate the recurrent application issues / bug fix.
- Represents the application in integrated Landscape and works with other Platforms (i.e. SAP, IRT etc) for mitigation of issues at interface level.
- Support Internal audits / health authority inspections.
- Provide assistance in the remediation of deviations related to IT systems, ensure follow up and monitoring of associated corrective and preventive actions.
- Review and approve the IT system validations reports.
Essential Requirements:
- 9+ years of practical experience in chemical / pharmaceutical industry or > 3 years of experience in field of expertise
- Working Knowledge Drug Development process or QA
- Experience on handling IT systems as Key user / Super User/ System Owner
- Basic project management, good organization and planning skills
- Knowledge of relevant regulations (e.g. GMP, HSE etc.) and Novartis specific standards.
Desirable Requirements:
- Bachelor / Masters Degree with experience in Pharmaceutical Industry/ specifically GMP background.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
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: https://talentnetwork.novartis.com/network.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
