Director, PV QA DSI

Location: Basking Ridge

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job Summary The Director, PV QA DSI will be a leader in the planning and implementation of the Quality Assurance strategy within the Clinical Safety and Pharmacovigilance (CSPV) function in the US (as applicable). The Director, PV QA DSI will provide operational PV QA involvement and ensure requirements are in place for quality oversight of Daiichi Sankyo products. The incumbent will collaborate and communicate with senior management, CSPV, and other QA functions to reflect proactive advisory responsibilities, and support continuous improvement initiatives.

The Director, PV QA DSI is accountable for driving a proactive approach to quality and fostering a shared commitment to building a stronger Quality organization – speaking with One Quality voice and serving as a trusted quality partner to both internal and external stakeholders. This position will collaborate with Global Audits and Compliance, Development and Medical QA, and GMP QA to ensure comprehensive quality oversight, and engage with external partners as deemed necessary.

The incumbent is expected to represent PV QA and partner with stakeholders such as Legal (where applicable), Regulatory Affairs, GMP QA, and Quality Management Systems to embed quality principles into processes and proactive risk mitigation. Ensure requirements are in place for quality oversight of marketed products under REMS program in collaboration with internal PV QA stakeholders such as GMP QA, specifically for GDP requirements, risk-based assessment for Distributors, vendors, and pharmacies.

Liaise with Audit and Compliance team to provide strategic oversight of the REMS audit framework, ensuring alignment of priorities and objectives. Review risk assessment documents stemming from audit outcomes to drive improved compliance across CSPV and other impacted stakeholders. Improve PV QA engagement with the relevant stakeholders at the regional DSI level as well as influence at the regional and global level pertinent to metrics, lessons learned and improved processes.

Lead proactive and strategic engagement and alignment with CSPV, providing operational PV QA guidance and advisory support to enable compliant regulatory execution and sustained adherence to procedural and training frameworks. Provide end-to-end safety consultation impacting REMS products from a quality perspective. Provide regular updates to management on the PV QA strategy and recommend refinements to objectives as needed to ensure continued alignment with organizational priorities.

Deliver methods for risk areas/process improvement to stakeholders via the QMS scheme (i.e., Quality Management Review, Quality Review Board) across the impacted organization leaders and relevant internal and external stakeholders. The role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas.

The role will manage PV QA resources in the US, in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of US team, performance management and contributing to organizational efficiencies.

Job Description Responsibilities Provide PV QA oversight of the company products, in alignment with the business strategy. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.

Act as the PV QA REMS representative during US FDA inspections.

Lead the facilitation of a structured lessons learned framework in collaboration with stakeholders on audits, inspections, regulatory intelligence, and process improvement. Provide operational PV QA leadership and guidance to CSPV teams, ensuring compliance with regulatory requirements and the maintenance of robust quality management systems. Ensure adequate oversight of Quality Events and CAPA management, ensuring timely escalation and remediation,.…