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,. Proactively ensure sustained compliance across all PV-related functions, providing strategic PV QA oversight and advisory support to CSPV on procedural adherence and training needs. May be tasked as a PV QA reviewer to support/ lead the review of the safety section of the dossier for regulatory submissions in collaboration with the Audit and Compliance team Ensure that PV topics, risks, respective product profile targeting the population are addressed from a PV QA standpoint and represent PV QA at respective governance meetings as necessary. Support Head of PV QA Americas in ensuring robust management review of quality and compliance topics including the oversight of Key Quality Indicators (KQIs) and provide strategic PV QA recommendations to drive continuous improvement. Ensure proactive identification and mitigation of safety and compliance concerns in collaboration with business functions, and initiate and lead cross-functional quality and compliance improvement initiatives at local and global level.
Provide strategic direction pertinent to REMS activities for internal QA team (global/ local), and not limited to: Global Project teams, Safety Management, Clinical Safety and Pharmacovigilance, Companion Diagnostics/ Device, Pharmacies, Vendors/ CRO and Commercial
Create a high performing team environment and a cohesive culture driven by values of integrity, respect, and culture of speak up. Lead and hold others accountable to performance, talent, and development objectives. Create an environment that fosters diversity of thoughts, inclusivity and one that adheres to the principles set forth in the organization (JOIN, GROW, THRIVE). Create an environment that thrives on innovation, proactive quality and is disciplined to efficiently execute against pre-defined deliverables. Drive employee engagement, mentoring, coaching and performance management.
May deputize for the Head PV QA Americas at Leadership team forums, as appropriate and as needed. Work with Head of PV QA Americas to plan, develop and implement PV QA strategy, metrics, dashboard, and project management methodologies for an efficient and effective organization. Champion Daiichi Sankyo’s Quality policy and Quality Culture, fostering a commitment to excellence and continuous improvement across CSPV functions.

Responsibilities Continued

Qualifications

Education Qualifications
Bachelor's Degree Bachelor's degree in scientific, health care or related discipline; and/or background in Medical Health profession (RN, Medical Technologist, etc.). Master's preferred required Master's Degree preferred

Experience Qualifications
10 or More Years 10 or more years of proven record in leading aspects of PV QA, involvement in regulated PV activities, in CSPV and PV QA (preferably) positions, or equivalent experience required. required
10 or More Years 10 or more years working knowledge of drug development process to commercialization. preferred
10 or More Years thorough and extensive knowledge of international GCP, GVP regulations and guidances including FDA, Health Canada, and ICH. preferred
10 or More Years Excellent verbal and written communication skills/ computer skills preferred
Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation.
Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas, and proven track record in leading teams and/ or working groups.
Experience in PV QA oversight of REMS programs is considered an advantage.

Additional Information