Senior Development Quality Assurance Specialist

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. This includes ensuring adherence to ICH GCP and GPvP guidance documents, Novartis written processes, acting as the QA subject matter expert for the approval of local GCP/PV procedures and supporting local IMP release process such that it is done according to global and local requirements.
• 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. Utilize lessons learned from audits, inspections, KQI reviews and day-to-day oversight of quality performance to recommend and initiate continuous improvement efforts.
• Training systems: Ensuring 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. Assure that relevant business areas are maintaining inspection-ready documentation to support reviews of training compliance.
• 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. Take accountability for escalation of GCP/GPvP process non-compliance as needed.
• Risk Identification and Management: Support monitoring local Quality System, processes and Key Quality Indicators (KQIs) to proactively identify potential quality risk. Collaborate with business partners to ensure that risks are reviewed for root cause, impact, and recurrence and assure that relevant line function owners put in place mitigation plans to address. Ensure adequate and timely escalation of issues to relevant functions as needed.
• Inspection Management and Support: Provide support as needed for GCP and GPvP HA inspections of activities in assigned country(ies). Assure support prior to, during and post inspection for the country organization, investigational sites and/or external service providers, as applicable, in collaboration with the assigned inspection lead. Ensure that responses to local Health Authorities are submitted on-time, commitments are agreed internally and can be met and relevant CAPAs have been completed/closed according to agreed timelines.
• Audit Management: Partner with local and global Development teams, PS, NCQ and other internal stakeholders in the execution, where QA processes are subject to the audit, and follow-up of audits on clinical development and PV activities. Collaborate with the business, and auditees as appropriate to determine root cause for identified audit and inspection observations (any audits and inspections related to clinical/medical, PV related areas) and verify robust and sustainable corrective and preventive actions are implemented.
• CAPA management: Act as local approver for the documentation and management of local CAPAs to support appropriate review and closure of each corrective and preventive action. Assure local line functions take appropriate ownership of duties as required by the CAPA processes.
• 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 (including POPs). Ensure the ESP selection, PV / QA agreements and oversight processes are properly followed at the CO for ESPs supporting Development activities with a clinical/medical or PV component (including POPs).
• 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 (ex: Quality committee), and ensure any identified trends/risks related to PV or GCP are communicated and addressed in a timely manner. Partner with local country quality team to ensure the analysis, assessment and resolution of issues with common interfaces (including CAPAs). Support the coordination and analysis of the  clinical/medical and PV section of the AQMR. Support the maintenance of the business continuity plan and the resulting measures that are implemented in GCP and GPvP areas.

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! Learn more here: https://www.novartis.com/about/strategy/people-and-culture

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.

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