Development QA Manager

Sep 22, 2021

Job Description

●The Development Quality Assurance Manager is responsible for assuring quality over-sight for activities undertaken in a country to assure compliance with relevant Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) regulations and guide-lines 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, oversight of local Investigational Medicinal Product (IMP) release, and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies).
●The Development Quality Assurance Manager is responsible for assuring the quality and compliance of Global Drug Development (GDD), Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local GDD colleagues (Trial Management Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to Novartis 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.
●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 sup-port prior to, during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the as-signed inspection lead. Ensure that responses to local Health Authorities are submit-ted on-time, commitments are agreed internally and can be met and relevant CAPAs have been completed/closed according to agreed timelines.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Global Drug Development
Full Time

Development QA Manager

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