Job ID278075BRPosition TitleATMP QA ManagerApply to Job
Job Description
10 days! That is how long we treat a patient’s T-cells before we return them to potentially save the patient’s life. Supporting such novel, personalized treatment by defining and implementing the microbial control strategy is a unique challenge within Novartis with immediate patient impact. This is a role waiting for you to put your own stamp on it.
Your responsibilities will include, but are not limited to:
- Release Activities: Responsible for the release and non-release of product batches of marketed goods as delegated by the Responsible Person
- Coordination of actions in collaboration with the Quality Responsible Person and NEM Coordinator in Quality incidents and (potential) recall situations of commodity batches of authorized products
- Ensure import and export of pharmaceuticals conforms with local regulations, e.g. distribution of foreign printed packaged materials in case of stock outs
- Audits & Inspections: Ensure CPO readiness for all GxP regulatory inspections. Provide support prior to, during and after HA inspections and internal audits of the CPO and external service providers, as applicable, together with the Novartis inspection lead
- Ensure that responses to local Health Authorities will be submitted within given timelines, commitments have been met and relevant CAPAs have been completed/closed
- Vendors: Conduct vendor assessment and/or qualification visits for locally outsourced GMP/GDP activities. Responsible for update and maintenance of Quality Agreements with vendors in the area of scope
- Metrics: Conduct proactive in-process quality and compliance review through monitoring of adequate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk
Minimum requirements
- Eidg. dipl. Apothekerin or comparable education (PhD, Master) with experience in GMP area
- German, English, French as advantage
- 2-4 years professional experience in analytics, quality assurance, production, distribution or pharmacy
- Experience in the area of Genetherapy (TpP/GT/GvO) products as Advantage
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.DivisionNovartis Technical OperationsBusiness UnitNTO QUALITYLocationSwitzerlandSiteRotkreuzCompany/Legal EntityNovartis Pharma Schweiz AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular
