Development Quality Assurance Manager (GCP/GPvP)

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About The Role

Tel Aviv, Israel (Hybrid) Hybrid

We are seeking a Development Quality Assurance Manager to be responsible for assuring quality oversight 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). You will operate in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs), Medical Affairs and Country QA to ensure compliance to Novartis entities requirements and relevant HA regulations and guidance.

This role will work directly with the Country Development Quality team and reports to the Head, Clinical & PV Region/Cluster Quality GDQ.

Commitment To Diversity & Inclusion

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

Role Requirements

Key Responsibilities

• Overseeing 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.
• Supporting and monitoring 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.
• Ensuring adequate training systems are in place in assigned country(ies) for GCP, GPvP and other relevant.
• Assuring that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.
• Driving Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Taking accountability for escalation of GCP/GPvP process non-compliance as needed.
• Partnering with local and global Development teams, PS, NCQ and other internal stake-holders in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities.
• Acting as local approver for the documentation and management of local CAPAs to sup-port appropriate review and closure of each corrective and preventive action. Assuring local line functions take appropriate ownership of duties as required by the CAPA processes.
  
  

Essential Requirements

• Degree in relevant field, or relevant business experience.
• Fluency in English (both written and oral).
• 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance.
• Strong project management experience.
• Solid experience with the handling of quality issues (CAPA, deviations).
  
  

Desirable Requirements

• 3 years experience in clinical development.
  
  

Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network