• Provide quality consultation within assigned scope, escalating complex or enterprise-impacting issues to the Senior Global Quality Manager and/or Global Head - GCP Excellence, as appropriate • Lead issue assessments, root cause evaluation, and recommendations for QA escalation • Lead cross-study quality initiatives to define best practices, enhance quality maturity, and strengthen proactive risk identification • Support teams in interpreting and applying ICH GCP, regulatory expectations, procedural documents, and governance frameworks • Provide direction for deviation management, CAPA development, and quality-related storyboards • Promote a culture of quality, continuous improvement, and operational excellence that engages colleagues in positive dialogue consulting and supporting in all we do • Develop, contribute, and support facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, as assigned • Contribute to the enhancement or creation of SOPs, WIs, guidance documents, and process optimization initiatives. • May drive continuous improvement projects aimed at strengthening quality culture, efficiency, and inspection readiness maturity • Provide training or awareness for new or established processes or guidance provided by QuIP • Collaborate in developing and presenting QuIP content for distribution within the organization • Author relevant content for the QuIP SharePoint sites • May act as lead on specified QuIP workstreams or assigned QuIP initiatives • Provide consultation and support for ad hoc requests that are sent to QuIP • Consult, develop, or identify opportunities for continuous improvement projects • Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials • Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus • Support overall quality within assigned clinical trials and submissions • Provide risk-management, consultation, assessment, and recommendations for escalation for potential quality issues or trends • Provide training and coaching to promote awareness educating study teams towards quality deliverables • Support teams in adherence to GCP and procedural documents and processes to ensure quality deliverables • Work with teams to escalate quality issues with CROs to QA, support teams to bring CROs into compliance; and look for opportunities to collaborate with other members of QuIP to trend across Strategic Partnership(s) to communicate to QA. • Support inspection readiness, preparation and conduct activities with the Study CTM/Sr. CTM, Asset Lead, QA Representative, and QuIP Leadership or designee as requested by the QuIP Inspection Excellence team. • Review critical/major findings with QA Audit reports to propose process improvement • Provide consultation on KQI or metrics that may identify emergent issues or trends or demonstrate strong adherence to quality.