The Country Pharma Organization (CPO) Quality Manager is responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV), as well as GxP activities related to Marketing.
Ensure in direct collaboration and partnership with the Country Organization Medical Department Drug Safety, Drug Regulatory Affairs and Medical Affairs) and Marketing Departments the implementation of the Novartis Quality Management System in the Country Organization to achieve a high level of quality and compliance.
1. Quality Management System : Implement and maintain the local Quality System in the areas within scope, in accordance with the Novartis Quality Manual, the local Quality Plan, and the local regulatory requirements (Implementation of global quality documents in the Country Organization, Contribution to the local Quality Plan preparation, implementation and follow-
up, Contribution to the Quality Risk Assessments).
2. Metrics : Report monthly Key Quality Indicators within scope of responsibilities, monitor them and assure that gaps are addressed appropriately in order to mitigate risk.
3. Vendors : Provide guidance and oversee External Service Providers and Patient Oriented Programs activities in the Country Organization through interactions with the line-
functions and stakeholders involved according to current SOPs.
4. Marketing : Assist the Marketing Program Owners in developing the CAPA Plan to correct any deficiencies identified during the POP vendor assessment and sign the CAPA plan.
5. Audits : Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance related audits at the Country Organization, at vendors and at investigator sites.
6. Inspections : Support CPO readiness for all GxP regulatory inspections and internal audits. Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead.
Ensure that responses to local HA have been submitted, commitments have been met and relevant CAPAs have been completed / closed.
7. Self-Inspections : Contribute to the preparation and updating of the Country Organization self- inspection plan and perform and / or provide guidance for the preparation, conduct and follow-
up of self-inspection activities in the areas of scope according to the approved self-inspection plan.
8. Deviations and Issues Management : Ensure that deviations and issues are properly managed in the internal track wise system including the respect of the escalation process.
Participate in QA investigation activities, as appropriate.
9. Training : Ensure that line-function heads implement appropriate training plans for their associates performing GCP / PV related activities.
10. Release Activities : Responsible for the release and non-release of Investigational Medicinal Products and related labels and packaging materials in close cooperation with the QA Dev Associate as delegated by the Responsible Person.
Ensure that all IMP release-related documents are filed in the related database.
Degree in Life Sciences or related fields
Minimum 5 years’ experience in the pharmaceutical industry in clinical development or a directly related area
Experience as a Clinical Research Associate (CRA)
Good Clinical Practice (GCP) experience
German and English fluent in speaking and writing