Clinical Document Mgmt. Inspection, CAPA and Risk Oversight Manager

Location: #LI-Hybrid ; #LI-Distance WorkerClinical Document Governance Management (CDGM) is accountable for strategy and delivery of clinical document management (CDM) systems, processes, standards and operations of CDM services (including Trial Master File management (TMF), clinical submission readiness, record retention and archiving, Good Documentation Practice capability build) across Novartis globally. In addition, CDGM is driving the transformation of TMF at Novartis, through the introduction and adoption of new technologies, processes and ways of working.This individual contributor role is accountable for coordinating or supporting Health Authority Inspection, internal audits and other quality related issues, as well as risk management, in relation to clinical document management at Novartis.Key Responsibilities:• Act as CDGM POC for Health Authority Inspection and internal audits - coordinating preparation, support and addressing findings, including identifying root causes of findings, creation of CAPAs and efficiency checks, monitoring of CAPA execution to ensure results are achieved in line with desired improvement and agreed timeframes.• Identify and be responsible for implementation of Health Authority Inspection and internal audits from inspections/audits to improve clinical documentation process, systems and capabilities.• Partner with network of CDGM Quality responsible persons (QARPs), business and QA partners to ensure Quality Issues and Quality Events are identified, assessed, handled and resolved optimally in line with Novartis processes - with root causes assessed, and lessons lea applied to future ways of working.• Member of cross-functional teams on business process, performance or system improvement initiatives focused on improving inspection readiness and TMF Health.• Partner with key risk management and QA customers to ensure a robust risk management framework is in place for CDGM, aligned to Novartis risk management standard processes.• Support consistent identification, evaluation and tracking of CDGM service risks, including identification of risk mitigation owners and development of robust risk mitigation plans.• Support development of CDGM staff capabilities in relation to inspection/audit support and to embed risk-based approaches into CDGM service delivery.• Maintain an awareness of the external regulatory environment and Novartis processes for inspection/audit support, and risk management and apply those to CDGM ways of working. **The ideal location for this role is the East Hanover, NJ site but a distant working arrangement may be possible in certain states. Distant workers are responsible for the cost of home office expenses and periodic travel/lodging to the East Hanover, NJ site, as determined necessary by hiring manager. This position will require minimal travel as defined by the business (domestic and or international).