Join a Legacy of Innovation 125 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
JOB SUMMARY
The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned with the Global Oncology Medical Affairs (GOMA), Oncology Business Unit (OBU) and Specialty Business Unit (SBU) Medical Affairs business strategy . This individual is also accountable to promote a quality culture within across the product portfolio by providing governance support, quality oversight of strategic initiatives in close collaboration with cross functional leadership team (ie, OBU, SBU) and study teams to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials and managed access programs to the highest quality standards.
This position reports to the Head, Global Development and Medical Affairs QA RDPVQA, and oversees multiple levels of direct reports (Directors, Associate Directors, Managers, contractors as applicable) across the Global Quality teams located in EU, Americas (including Brazil) and work in close collaboration with Japan. This individual is a member of the Development and Medical Affairs QA leadership team and maybe extended member of the global RD/PV QA leadership team. The position will represent QA at Global Oncology Medical Affairs LT, Specialty MA 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.
Provide comprehensive quality oversight and strategic quality guidance/advice to the MA functions located in the Americas and EU and collaborate with Research QA and Development QA to provide QA advise wherever necessary for shared services between R&D and Medical affairs, particularly in case when issues impact Medical Affairs programs. Ensure requirements are in place for quality oversight of marketed products in collaboration with Research QA, PV QA, CSPV and other internal QA stakeholders such as GMP QA, specifically for specialty pharmacy, REMS, co-partners and affiliates.
Liaise with Audit and Compliance team to ensure that Global Medical Affairs audits are properly planned, communicated and that audit targets for MA audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within MA function. Improve/strengthen QA engagement with Global Oncology Medical Affairs, Specialty Medical affairs, through lessons learned, process improvement and ongoing collaborations.
Provide end to end process consultation impacting products from a quality perspective. Provide regular updates to management on Mid Term strategy (MTS) for MA QA area and propose improved objectives as necessary. Deliver risk mitigation strategies and process improvements to stakeholders via the QMS framework (i.e., Quality Management Review, Quality Review Board) across the global medical affairs organization (Oncology and SM) and relevant external stakeholders.
The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC and EU):in an efficient and effective manner including, but not limited to oversight of defined work products, coaching and mentoring of global team, performance management and driving/contributing to organizational effectiveness/efficiencies.
RESPONSIBILITIES
Customer Focus
Oversight:
Provide strategic direction pertinent to MA activities for internal QA team (global/ local), but also to:
Leadership/ team management:
External Engagement:
Strategy:
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