Development Quality Assurance Team Lead

**Summary**:
The Development Quality Assurance Team Lead is responsible for 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 (NCQ) to ensure compliance to Novartis entities requirements and relevant HA regulations and guidance. Ensures implementation of the Novartis Quality Manual and Quality Management System in as-signed country(ies) to achieve a high level of quality and compliance.

The Development Quality Assurance Team Lead is responsible for leading complex investigation, leading major health authority inspections and leading novel projects (e.g. developing quality risk management strategies in novel situations)

Localisation : Rueil-Malmaison, France #LI-Hybrid

**About the Role**:
**Major accountabilities**

**(include, but are not limited to)**
- Quality Plan and Continuous Improvement: Support and monitor 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: Ensure 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: Drive 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: Monitor 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 leadership and/or 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.
- 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: Responsible for the execution of QA activities required for the qualification/requalification of ESPs supporting activities with a clinical or PV component. 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.
- Data integrity: Ensure that there is a process 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: Lead/co-lead 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. Ensure a process is in place to update local functions on the possible impact of changes to local and/or global requirements and regulations. Ensure there is an appropriate interface with internal/external stakeholders for any GCP/PV related activity (e.g. local Health Authority, clinical and PV related changes/initiatives). Partner with local NCQ team to ensure the analysis, assessment and resolution of issues with common interfaces (GCP/PV and GMP). Coordinate and analyze clinical and PV section of the AQMR. Ensure business continuity plan is maintained and resulting measures are implemented in GCP and GPvP areas.
- Investigational Medicinal Product (IMP): Ensure oversight of local IMP release

**Background/ Experience required**
- Degree in Life Sciences or related fields
- English (fluent)
- At least 7 years’ experience in the pharmaceutical industry in a relevant field such as quality assuran