Job for B.Pharm as Head in Clin&PV Region at Novartis

 

 

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Head, Clin&PV Region/Cluster Quality GDQ

Job Description
Provide strategic & proactive QA Leadership to Country & Regional GDQ Associates within a defined Cluster of countries or a Direct Country, linking global & local GxP strategy for clinical (including clinical supplies/investigational product) & pharmacovigilance quality, across NVS divisions (Novartis Pharmaceuticals, NVS Oncology, Sandoz Biosimilar & small molecules) covering all clinical programs (phase I to phase IV, including IITs, NIS, MAP programs) for the entire NVS Portfolio. Drive & implement the clinical, investigational Medicinal Product (IMP) & pharmacovigilance (PV) QA strategy throughout the countries under responsibility in close collaboration with Global Development QA Functions & NVS County QA (NCQ), to ensure regional//local QA oversight & support of GCP, GMP/IMP & PV activities. Implement the defined governance structure together to ensure appropriate QA oversight, adherence to global/local regulatory requirements & NVS procedures, reporting & escalation within & across the countries under responsibility & up to Global Development QA (GDQ). Develop strategies across the Country Organizations under responsibility by implementing the shared Global vision for proactive, preventive QA where trends & prior issue resolution are translated to best practices that can be applied earlier in the product life cycle. Foster & champion a QA culture & a QA mindset where a QA Management System is jointly maintained with all business process owners within the Countries.

Responsibilities:

  • Ensure global & local objectives, priorities & deliverables are translated into one end-to-end QA oversight program for GCP, PV & IMP activities within Countries under responsibility (covering all clinical programs).
  • Build, lead & retain a team of high-performing QA professionals within countries under responsibility, evaluate, mentor & coach individuals on team to develop & retain QA leaders as well as build a culture of high performance & impact.
  • Oversee objective setting & performance management process among GDQ Associates within assigned Countries.
  • Member of CQA Country QA Leadership team, representing assigned Cluster/Country framework for GCP,PV & IMP.
  • Ensure development & deployment of QA reviews with assigned countries; Chair QRBs for Development activities & ensure close partnership with GDD in assigned countries.
  • Represent QA at respective Country/Region divisional leadership team meetings/Quality Committees/Quality Review Boards together with NCQ Leaders & wherever necessary provide strategic QA & business input impacting QA & compliance activities. Support & drive implementation & execution of QA strategy from GDQ & key stakeholders in Country Organizations, Divisions/BU (as set forth in annual QA Plans).
  • Ensure up-to-date status reporting on progress of QA plans deliverables, Key QA Indicators & key initiatives to relevant Country Organization key stakeholders & Global functions within GDQ.
  • Ensure applicable clinical development & PV processes & QA standards are implemented within & across countries, in line with worldwide HA requirements.
  • Work with CMO & Patient Safety QA to build PV expertise in GDQ in countries. Drive strategic deployment of cross-divisional lessons learned throughout assigned Country Organizations in clinical development, based on trends from audits, inspections & deviations/incidents; Ensure a robust learning management system is in place in each assigned country that supports business deliverables and associates’ training needs & that compliance is monitored. Ensure within assigned Countries, a process is in place for effectiveness checks & assessment of metrics, KQIs & regulatory surveillance for continuous improvement. Provide oversight of local regulatory inspections & ensure a robust system is in place to execute readiness activities at all levels throughout assigned countries/region. Implement & maintain a robust CAPA management system to support continuous improvement efforts across assigned Countries/Region.

Additional Information
Experience : 5 years
Qualification : Degree in Life Sciences, Pharmacy or Medicines
Location : Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 30/05/2019

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