Quality Compliance & Standards Lead, RWE Platform

ROLE SUMMARY

The Quality Compliance & Standards Lead(s) (QCSL) are key members of the Evidence Generation Team and are aligned by Therapeutic Area (TA). The QCSL are responsible for supporting the quality oversight for implementation of research and studies conducted in the global RWE Platform.  This role will coordinate and facilitate quality, vendor oversight and training activities cross functionally for the BU related to Evidence Generation study activities, provide guidance to study team for ensuring correct study type and application of safety reporting rules for study type.  Additional involvement in quality activities will include: audit preparedness, quality event reporting/ CAPA development and remediation, vendor oversight, new process development & implementation and audit response.

The RWE Platform QCSLs will provide quality oversight of the conduct of global epidemiological studies, collaborative research, noninterventional and low interventional studies (LIS) types 1&2 to support the Integrated Evidence Plans (IEP) and strategic goals of all regions including IDM and EM.  All study types are within remit including PMCs, PMS, PAES and voluntary & committed PASS and epidemiological studies across the asset life cycle from POC onwards.

The QCSLs will collaborate globally and cross functionally with clinical affairs, medical affairs, RWE partner/ platform, RWE Scientists and other stakeholders to ensure global consistency, governance and compliance by deploying fit for purpose training, oversight, processes/procedures and the regular update of existing SOPs to adjust for innovation and high quality evidence generation.

ROLE RESPONSIBILITIES

TA-Level Quality Oversight

• Collaborate with cross-functional teams to ensure RWE plan strategy and asset-level risks are incorporated into study and asset-level quality oversight to support participant data rights, safety and the reliability of trial results.
• Strategically utilize quality measures/data to monitor portfolio quality to understand and recognize potential risks, identify trends, and support state of quality reporting.
• The QCSL role will provide a single point of accountability supporting quality in sourcing strategy, vendor selection, assessment, onboarding, oversight, and performance management for a set of established vendors within a service category or across multiple types of services.  
• Address and triage questions pertaining to quality within Evidence Generation scope; escalates issues appropriately within the QMS structure.
• Communicate key quality information across asset/study teams and serve as TA quality expert.

Study-Level Quality Oversight

• Provide study teams with guidance on high risk activities, by utilizing quality metrics and ensuring  quality deviations are identified and addressed in a timely and appropriate manner.
• Active member of governance review boards for high priority Assets/protocols.
• Provide study teams with guidance and assistance to assess vendors, manage quality vendor oversight, vendor training.
• Quality review of regulatory submission projects/ protocol drafts, to ensure studies are conducted in compliance with relevant SOPs and applicable internal, external, regulatory requirements.
• Quality Oversight for study types conducted in the real-world evidence generation platform including Non-Interventional, Low Interventional and Collaborative Research.
• For collaborative research the QCSL provides quality oversight and quality planning with the external sponsor/ CROs partners and internal RC Manager and RC requestor to ensure all EvGen Platform proposed research collaborations are compliant with relevant internal governance and external regulations.

Audit & Inspection Readiness and Preparation

• Provide Study Team with Audit & Inspection Readiness (IR) guidance and support.
• Develop and maintain inspection readiness tools and processes, as appropriate for RWE Platform and in alignment with RQA/CQA.
• QCSLs work in collaboration with Study Teams and Audit Lead to prepare for and manage internal and external audits to ensure inspection readiness. 
• Provide guidance and focused support to asset teams and pivotal study teams that have a high likelihood of internal audit and regulatory inspection.

Business Development/Data Use Assessment Management

• Quality representative of the Evidence Generation/ RWE team for business development opportunities.
• Collaboration with data partnership platform to provide strategic input to risk-based quality approaches related to data use and acquisitions, as needed.

Technology/Process Improvement

• Partners with the Clinical Affairs & Operat