Associate Director PV Quality, Americas

Job Summary

Participate in the implementation of the quality strategy closely aligned with the business strategy within the CSPV function. Provide strategic and proactive QA Leadership and support development Project Teams and CSPV with adequate quality and compliance guidance in close alignment with the Head of Global PV QA Americas. Including, daily consultation to CSPV unit to harmonize end to end "proactive quality".

Advise development teams in quality and compliance decision making to drive sustainable quality and compliance excellence. Provide quality and compliance guidance for process deviations and implementation of corrective and preventive actions, including enhanced involvement on Root Cause Analysis (RCA); monitor their status and timely closure. Support risk management activities, including trend analysis KQIs (e.g. Audits, Inspections, QIs including late ICSR submission of reports, and their CAPAs, etc.)

from a PV Quality perspective. Ensure adequate regulatory inspection and audits preparation. Responsible for the coordination and support CSPV for preparation. Participates in PV inspections/Audits. Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all CSPV matters for the Project Teams and CSPV. Provide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas.

Facilitate the implementation of the quality strategy in close alignment with the CSPV business strategy. Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported CSPV teams, including the quality risk assessments and inspection readiness components for the designated programs. Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions.

Participate in the development and/or enhancement of CSPV Strategy and PV/GxP QA business processes, procedures, and best practices. Support the Head of PV QA, Americas with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.

Interact with the audit function. The respective CSPV groups and respective CROs, Partners and Affiliates in order to ensure high data quality and proactive detection and resolution of issues. Actively participate in special assignments on various project teams and work streams as determined by QA management. Effectively communicate with CSPV, by interacting with other GxP QA functions (R&D Quality, GMP/IMP QA, Audit, Quality Standards and Procedures QA and in close collaboration with CAPA Manager.),

on CSPV topics/issues impacting the respective Pharmacovigilance operations and safety activities. Collaborate with CSPV and Global PV Quality on quality review of PV and REMS documents, including SOPs, Pharmacovigilance Site Master File (PSMF) audit content, and REMS material. Help to ensure in collaboration with CSPV or other business process owners that applicable CSPV processes and quality standards which are in line with worldwide HA requirements are implemented.

Help to establish in built controls in relevant process steps to ensure adherence to regulatory compliance. Keep abreast of changes in regulations and enforcement actions and make recommendations for changes to Daiichi Sankyo’s policies and practices to maintain proactive compliance. Quality Oversight: a. Ensure adequate and timely escalation of incidents/issues within CSPV and QA. Lead formal investigations of issues as they arise, ensuring timely escalation to line management if critical observations are not resolved in due course.

b. In collaboration with GxP Quality Systems and Compliance provide Quality oversight for deviations/incidents & investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked. Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA). Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions. c. Ensure that proper Quality oversight is implemented for 3rd parties/vendors/outsourced activities.

In collaboration with CSPV develop Lessons learned information flow at the CSPV operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement. Ensure continued submission and inspection…