Director, PV QA DSI

Job title: Director, PV QA DSI

About the Role The Director, PV QA DSI will lead the planning and implementation of the Quality Assurance strategy within the Clinical Safety and Pharmacovigilance (CSPV) function in the US (as applicable). The incumbent will provide operational PV QA involvement and ensure requirements are in place for quality oversight of Daiichi Sankyo products. The role will collaborate with senior management, CSPV, and other QA functions to reflect proactive advisory responsibilities, support continuous improvement initiatives, and foster a One Quality culture as a trusted quality partner to internal and external stakeholders.

What You'll Do

• Provide PV QA oversight of company products, in alignment with the business strategy.
• Lead PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for regulatory inspections in alignment with regulatory and company strategy, including coordinating CSPV teams and 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 profiles 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, CSPV, 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 a culture of speak up.

What We're Looking For

• Extensive experience in Pharmacovigilance Quality Assurance (PV QA) within CSPV, with proven track record in regulatory inspections, REMS, CAPA, and QMS.
• Strong collaboration and partnership with Legal, Regulatory Affairs, GMP QA, and Quality Management Systems.
• Demonstrated leadership of cross-functional teams and strategy development for PV QA.
• Experience with REMS programs and GDP requirements; risk-based assessment for distributors, vendors, and pharmacies.
• Excellent communication, oversight of KPIs/KQIs, and ability to translate regulatory expectations into actionable processes.

Nice to Have

• Experience with REMS program execution and GDP regulatory requirements in the US or globally.
• Exposure to global audits and compliance initiatives and interaction with external partners.
• Mastery of regulatory intelligence and lessons learned processes and ability to implement improvements.

Compensation & Benefits

• Salary and benefits are not disclosed in the posting.