Summary
About the Role
Major accountabilities:
- Maintains overview on projects ongoing at assigned CMOs.
- Maintain all assigned companies in a GMP approved status (tracking Third Party Assessment due date and address any need of the prerequisites, audit preparation, Quality Frame Agreement update, CET assessment).
- Drives performance control, quality reviews and 3rd party management reviews of assigned CMOs.
- Drives the governance meetings (EPM meetings) with those companies, ensuring cross-functional audience and contribution (Procurement, QA etc.).
- Ensure awareness of any change at assigned CMOs (equipment, capabilities, investment, changes etc.) by reporting them in the technology Matrix document.
- Contributes to team review of new projects requests by providing quality and technical information to new projects requests, provides assistance for technical clarification calls.
- Considers supporting project team with manufacturing documentation review for input as to compliance of template to agreed requirements and completeness of executed documentation versus agreed content (technical/ scientific content is project specific and up to the project team knowledge and assessment)
- Acknowledged coordination and communication within Novartis TRD RLT project teams and other functions (TRD QA, Procurement etc.) of the collaboration aspects.
Minimum Requirements:
- Master of science with 4-6 year of proven experience or Bachelor of Science with 6-8 years relevant experience
Skills:
- Awareness of all the pharmaceutical development technologies, regulatory guidelines, and relevant documentation.
- Pharmaceutical technology transfer experience is desirable.
- Good theoretical and scientific knowledge in the relevant area of expertise.
Languages :
- English.
- German desired
- Italian desired
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
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.
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.
