Pharma Jobs | Clin&PV Region Head Post Vacant @ Novartis

Pharma Jobs | Clin&PV Region Head Post Vacant @ Novartis

Applications are invited for the post of Clin&PV Region Head @ Novartis. Career @ Novartis. Pharma job opportunity at Novartis. Clin&PV Region Head post vacancy. Interested candidates may apply online. Check out all the details on the same below:

The job posting you are looking for has expired or the position has already been filled.

Job Id: 267391BR

Job Title: Head, Clin&PV Region/Cluster Quality GDQ

Eligibility: Pharmacy or Medicines

Experience:

advanced degree preferred. Fluency in English as a business language (oral & written). At least 5 years of demonstrated leadership & accomplishments in a global/matrix environment in the pharmaceutical industry. At least 5 years people management experience incl. experience in a matrix environment.

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.

Your 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.

The job posting you are looking for has expired or the position has already been filled.

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