Director, PV QA Americas

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.

The Director, PV QA Americas, reports directly to the Senior Director, PV QA Americas, Global R&D & PV QA. This position is accountable for instilling a consistent quality mindset and culture through partnering with stakeholders to streamline the development and the conduct of company's risk mitigation strategies. The Director will provide operational QA involvement, ensure requirements are in place for quality oversight of marketed products under REMS program, and oversee such programs from a QA perspective.

The incumbent will collaborate with internal QA stakeholders, including GMP QA, and support continuous improvement initiatives. The Director may represent QA at governance meetings and cross-functional projects as needed. The position will represent QA at Global CSPV LT, Development (as applicable), GMP QA, and engagement with external partners as deemed necessary. This position is accountable to drive a proactive approach to quality and instilling a shared passion for building a stronger Quality organization with One Quality voice as the best trusted quality partner with internal and external stakeholders.

The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Ensure requirements are in place for quality oversight of marketed products under REMS program in collaboration with internal 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 ensure that REMS audits are planned, communicated and that audit targets for tactical and strategic REMS audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within CSPV and other impacted stakeholders. Improve QA engagement with the relevant stakeholders at the regional DSI level as well as influence at the global level pertinent to metrics, lessons learned and improved processes.

Provide end to end safety consultation impacting REMS products from a quality perspective. Provide updates to management on MTS strategy for PV QA area and propose improved objectives as necessary. 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 external stakeholders. The role will participate in other PVQA Americas projects, tasks, and initiatives as needed and as instructed, including but not limited to including Quality Oversight for the Quality Plan execution, review of key REMS documents, Health Authority Commitments, Incidents, escalation process and the CAPA Management Process for the respective functional areas.

• Provide REMS quality oversight of the Oncology and Specialty Medicine portfolios, in alignment with the business strategy.
• Lead the REMS inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, specifically in the DSI.
• Act as the PV QA REMS representative for key health authority inspections such as US FDA, Health Canada, ANVISA, etc.
• In collaboration with stakeholders develop Lessons learned information flow at the operational level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement. Ensure adequate CAPAs are defined, implemented, and closed by providing guidance and facilitation of quality event resolution.
• Proactively ensure that all functions consistently operate in a state of compliance.
• May be tasked as a 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 REMS topics, risks, respective product profile targeting the population are addressed from a PV QA standpoint and represent QA at respective governance meetings where QA is necessary. Support Head of PV QA Americas to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs). Ensure that safety risks are duly identified, mitigated in collaboration with the business functions.
  
  Identify appropriate continuous improvement…