Novartis Pharmaceuticals East Hanover , NJ 07936
Provide strategic and proactive QA Leadership to Country and Regional GDQ Associates, linking global and local GxP strategy for clinical (including clinical supplies/investigational product) and pharmacovigilance quality, across Novartis divisions (Novartis Pharmaceuticals, Novartis Oncology, Sandoz Biosimilars and small molecules) covering all clinical programs (phase I to phase IV, including IITs, NIS, MAP programs) for the entire Novartis Portfolio.
Drive and implement the clinical, investigational Medicinal Product (IMP) and pharmacovigilance (PV) quality strategy throughout the countries in close collaboration with Global Development Quality Functions and Novartis County Quality (NCQ), to ensure regional//local QA oversight and support of GCP, GMP/IMP and PV activities.
Co-develop and maintain a governance structure together with the Global Head CMO & PS Regions and Countries QA and NCQ Regional Heads to ensure appropriate quality oversight, adherence to global/local regulatory requirements and Novartis procedures, reporting and escalation within and across the countries and up to Global Development Quality (GDQ).
Develop strategies across the Country Organizations by implementing the shared Global vision for proactive, preventive QA where trends and prior issue resolution are translated to best practices that can be applied earlier in the product life cycle.
Foster and champion a quality culture and a quality mindset where a Quality Management System is jointly maintained with all business process owners within the Countries.
Working together with all Global GDQ functions establish and advance well-defined processes with impact to achieve the highest data quality standards and protection of human subject rights- and, well-being through an end-to-end risk-based quality management process fully embedded to support all aspects of clinical trials, including surveillance of vendor-managed activities and business setups.
1.Ensure global and local objectives, priorities and deliverables are translated into one end-to-end quality oversight program for GCP, PV and IMP activities within the Countries (covering all clinical programs).
2.Build, lead and retain a team of high-performing quality professionals, evaluate, mentor and coach individuals on the team to develop and retain quality leaders as well as build a culture of high performance and impact
3.Oversee objective setting and performance management process among GDQ Associates within the Countries.
4.Ensure the right level of leadership is assigned within Regions/Countries for continual oversight of quality standards and controls for clinical trials, IMP and pharmacovigilance activities.
5.Member of CQA Leadership team, representing the Country framework for GCP, PV and IMP.
6.Ensure the development and deployment of quality reviews; Chair QRBs for Devel-opment activities and ensure close partnership with GDD in countries /regions Represent quality at the respective Country/Region divisional leadership team meet-ings/Quality Committees/Quality Review Boards together with NCQ Leaders and wherever necessary provide strategic quality and business input impacting quality and compliance activities
7.Support and drive the implementation and execution of the quality strategy from GDQ in close collaboration with the NCQ Regional Leaders and key stakeholders in the Country Organizations. divisions/BU (as set forth in the annual Quality Plans).
8.Ensure up-to-date status reporting on progress of quality plans deliverables,, Key Quality Indicators and key initiatives to the relevant Country Organization key stakeholders and Global functions within GDQ.
9.Ensure applicable clinical development and PV processes and quality standards are implemented within and across countries, in line with worldwide HA requirements.
10.Work with Global Head, CMO & Patient Safety QA to help build PV expertise in GDQ in the countries
11.Drive strategic deployment of cross-divisional lessons learned throughout the Country Organizations in clinical development, based on trends from audits, inspections, and deviations/incidents; Ensure a robust learning management system is in place in each country/region that supports business deliverables as well as associates' training needs and that compliance is monitored.
12.Ensure within Countries and Regions, a process is in place for effectiveness checks and assessment of metrics, KQIs and regulatory surveillance for continuous improvement.
13.Provide oversight of local regulatory inspections and ensure a robust system is in place to execute readiness activities at all levels throughout the organization
14.Implement and maintain a robust CAPA management system to support continuous improvement efforts across the Countries/Regions. In collaboration with other QA organizations (Global GDQ, NCQ, PLS, NIBR), foster a culture of information sharing and best practices to support high quality clinical trials and data
15.Identify and support strategic quality and business initiatives, including appropriate remediation programs, quality/compliance activities and affected changes, continuous improvement initiatives for quality and compliance related areas.