Summary
Location: London, UK
Working model: Hybrid working model (12 days per month in the office)
Note: Novartis is unable to provide relocation or visa support for this position.
The Senior Development Quality Assurance Specialist assists with 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. 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 and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies) in all Novartis entities. The Senior Development Quality Assurance Specialist is responsible for assisting in assuring the quality and compliance of Development, Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs, Medical Affairs and Novartis Country Quality) to ensure compliance to Novartis entities requirements and relevant Health Authority 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.
About the Role
Major accountabilities: Local Quality System:
Assist in the 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. Quality Plan and Continuous Improvement:
Support the 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. Training systems:
Ensure that 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. Quality Issue Management:
Support and facilitate Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Risk Identification and Management:
Support monitoring local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Inspection Management and Support:
Provide support as needed for GCP and GPvP HA inspections of activities in assigned country(ies). Audit Management:
Partner with local and global Development teams, PS, NCQ and other internal stakeholders in the execution of audits on clinical development and PV activities. CAPA management:
Act as local approver for the documentation and management of local CAPAs. ESP/Supplier Management:
Support the execution of QA activities required for the qualification/requalification of ESPs supporting activities with a clinical/medical or PV component. Data integrity:
Support the processes in place to maintain local quality and compliance with requirements for digital governance platforms and computerized systems with GCP and/or GPvP impact. Governance/Communication:
Support the local quality review board meetings and ensure any identified trends/risks related to PV or GCP are communicated and addressed in a timely manner. Key performance indicators: GCP/PV risks proactively identified and effectively mitigated. CAPAs are holistic, on-time and prevent issue recurrence. The number and severity of GCP/PV issues identified during internal and external audits is minimized. No regulatory delays are encountered due to inefficient local GCP/PV system. Country(ies) are inspection ready at all times. Role Requirements: Education Degree in life science or related field required. Experience Minimum of 5 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance, clinical development or a directly related area. Knowledge of GCP processes (preferably with experience as a Clinical Research Associate). Languages Fluent English (both spoken and written). 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! Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Division:
Development Business Unit:
Innovative Medicines Location:
United Kingdom Site:
London (The Westworks) Company / Legal Entity:
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area:
Quality Job Type:
Full time Employment Type:
Regular Shift Work:
No
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Location: London, UK
Working model: Hybrid working model (12 days per month in the office)
Note: Novartis is unable to provide relocation or visa support for this position.
The Senior Development Quality Assurance Specialist assists with 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. 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 and quality oversight of Clinical and Pharmacovigilance activities as needed in both pre- and post- market settings in assigned country(ies) in all Novartis entities. The Senior Development Quality Assurance Specialist is responsible for assisting in assuring the quality and compliance of Development, Global and local Medical Affairs (MA) & Commercial patient-facing projects, products and programs. Operates in direct collaboration with local Development colleagues (Study and Site Operations, Patient Safety and Regulatory Affairs, Medical Affairs and Novartis Country Quality) to ensure compliance to Novartis entities requirements and relevant Health Authority 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.
About the Role
Major accountabilities: Local Quality System:
Assist in the 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. Quality Plan and Continuous Improvement:
Support the 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. Training systems:
Ensure that 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. Quality Issue Management:
Support and facilitate Clinical/PV QA investigation activities at the country level as appropriate and ensure implementation of robust CAPA plans where applicable. Risk Identification and Management:
Support monitoring local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Inspection Management and Support:
Provide support as needed for GCP and GPvP HA inspections of activities in assigned country(ies). Audit Management:
Partner with local and global Development teams, PS, NCQ and other internal stakeholders in the execution of audits on clinical development and PV activities. CAPA management:
Act as local approver for the documentation and management of local CAPAs. ESP/Supplier Management:
Support the execution of QA activities required for the qualification/requalification of ESPs supporting activities with a clinical/medical or PV component. Data integrity:
Support the processes in place to maintain local quality and compliance with requirements for digital governance platforms and computerized systems with GCP and/or GPvP impact. Governance/Communication:
Support the local quality review board meetings and ensure any identified trends/risks related to PV or GCP are communicated and addressed in a timely manner. Key performance indicators: GCP/PV risks proactively identified and effectively mitigated. CAPAs are holistic, on-time and prevent issue recurrence. The number and severity of GCP/PV issues identified during internal and external audits is minimized. No regulatory delays are encountered due to inefficient local GCP/PV system. Country(ies) are inspection ready at all times. Role Requirements: Education Degree in life science or related field required. Experience Minimum of 5 years’ experience in the pharmaceutical industry in a relevant field such as quality assurance, regulatory affairs, pharmacovigilance, clinical development or a directly related area. Knowledge of GCP processes (preferably with experience as a Clinical Research Associate). Languages Fluent English (both spoken and written). 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! Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Division:
Development Business Unit:
Innovative Medicines Location:
United Kingdom Site:
London (The Westworks) Company / Legal Entity:
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Functional Area:
Quality Job Type:
Full time Employment Type:
Regular Shift Work:
No
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