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Working model: Hybrid working model (12 days per month in the office)
Note: Applications will be reviewed in January 2025.
About the role:
The R&D Quality Manager will independently manage projects and processes to support the technical R&D (TRD) portfolio. Providing quality assurance expertise, guidance and support to TRD project teams, to ensure compliance with cGMP and Novartis procedures and quality standards.
About the Role
Major accountabilities:
- Generation, Review and Approval of GMP relevant documents generated by TRD and/or TRD QA
- Batch release decision-making according to applicable procedures, with the authority delegated by Swiss FvP
- Oversight on the review of master and executed batch records performed by other QA members, including clarification of all deficiencies in GMP documents, and supervision of agreed follow-up
- Support project management functions as a project team member
- Supports audits and inspections in case of questions on assigned projects
- QA contact for assigned third parties, when applicable. In this context, supports on-site visits and audit preparations at CMO, follows up audit CAPAs, and supports review of CMO KPIs and input to Quality agreements.
Minimum Requirements:
- Master degree in scientific discipline (Chemistry / Pharmacy)
- Sound scientific, technical and regulatory knowledge.
- Fluent English both spoken and written
- Fluent German is an advantage.
Work Experience:
- 3+ years of proven experience in n operational Quality Assurance (within a Pharmaceutical environment)
- Good knowledge of cGMP, working knowledge in technical development, production.
Skills:
- Good organizational and decision-making skills
- Influencing skills.
- Resilience
- Self Awareness.
Note: Applications will be reviewed in January 2025.
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
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.
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
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
