Development Quality Assurance Manager/Expert

Novartis; Schweiz; Vor Ort; EUR 148.000 - 201.000; Vollzeit

Zusammenfassung

Novartis is seeking a Development Quality Assurance Manager to assure quality oversight for activities across country operations, ensuring GCP and GPvP compliance and patient safety. The role collaborates with local Development colleagues, Medical Affairs, and NCQ to implement the Quality Management System and ensure audit readiness and continuous improvement.

The position oversees local QA activities, quality plans, training, and CAPA management, coordinating inspections and risk mitigation

Qualifikationen

• Lead QA activities to assure GCP/GPvP compliance across country operations.
• Oversee local Quality System implementation and training readiness.
• Coordinate CAPA processes and inspections with global and local stakeholders.

Aufgaben

• Local Quality System oversight to ensure GCP and PV processes comply with global requirements.
• Develop and monitor the Quality Plan (QP) deliverables for GCP and PV areas.
• Ensure training systems exist for GCP, PV, and related Development activities; maintain inspection-ready documentation.
• Drive Clinical/PV QA investigations and implement robust CAPA plans.
• Identify and manage quality risks with root-cause analysis and mitigation actions.
• Provide leadership for GCP and GPvP HA inspections and post-inspection actions.
• Lead audit activities and follow-up with auditees to implement corrective actions.
• Approve and manage local CAPAs ensuring timely closure by responsible owners.
• Oversee ESP/Supplier QA activities in the local context.

Jobbeschreibung

Job Description Summary

The Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in all Novartis entities in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guidelines to assure the execution of high quality research and activities within a country(ies). Activities in scope include but may not be limited to assuring adequate systems are in place for the protection of patient safety, rights and well-being, data integrity, and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies) in all Novartis entities.

The Development Quality Assurance Manager is responsible for assuring the quality and compliance of Development, Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local De-velopment colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Novartis Country Quality (NCQ) to ensure compliance to Novartis entities requirements and relevant HA regulations and guidance. Ensures implementation of the Novartis Quality Manual and Quality Management System in assigned country(ies) to achieve a high level of quality and compliance.

-Manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations.

Job Description

Major Accountabilities

Local Quality System: Oversee implementation, maintenance, and monitoring of the local Quality System and written procedures to ensure GCP and Pharmacovigilance related processes and tasks are compliant with Novartis global requirements and applicable regulations and guidelines. This includes ensuring adherence to ICH GCP and GPvP guidance documents, Novartis written processes, acting as the QA subject matter expert for the approval of local GCP/PV procedures and supporting local IMP release process such that it is done according to global and local requirements.

Quality Plan and Continuous Improvement: Support and monitor implementation of the local Quality Plan (QP) deliverables related to GCP and PV areas, ensuring alignment with the applicable global QP chapters where ever possible. Utilize lessons learned from audits, inspections, KQI reviews and day-to-day oversight of quality performance to recommend and initiate continuous improvement efforts.

Training systems: Ensure adequate training systems are in place in assigned country(ies) for GCP, GPvP and other relevant Development activities in compliance with Novartis global and local requirements. Assure that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.

Quality Issue Management: Drive Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Take accountability for escalation of GCP/GPvP process non-compliance as needed.

Risk Identification and Management: Monitor local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address. Ensure adequate and timely escalation of issues to relevant functions as needed.

Inspection Management and Support: Provide leadership and/or support as needed for GCP and GPvP HA inspections of activities in assigned country(ies). Assure support prior to, during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the assigned inspection lead. Ensure that responses to local Health Authorities are submitted on-time, commitments are agreed internally and can be met and relevant CAPAs have been completed/closed according to agreed timelines.

Audit Management: Partner with local and global Development teams, PS, NCQ and other internal stakeholders in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities. Collaborate with the business, and auditees as appropriate to determine root cause for identified audit and inspection observations (any audits and inspections related to clinical/medical, PV related areas) and verify robust and sustainable corrective and preventive actions are implemented.

CAPA management: Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action. Assure local line functions take appropriate ownership of duties as required by the CAPA processes.

ESP/Supplier Management: Responsible for the execution of QA activities r