Director, Medical Affairs QA

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:

Reporting to the Sr. Director, Medical Affairs QA, the Director of Medical Affairs QA is responsible for providing strategic leadership and comprehensive quality oversight across all Medical Affairs programs. This role involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high impact projects, fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.

• Support the Sr. Director's Medical Affairs Quality strategy by partnering with members and business stakeholders for both Oncology and Specialty Affairs Medical Affairs teams. Will provide strategic and proactive QA Leadership and direction for respective interventional/non-interventional programs such as post marketing studies or post approval commitments, medical access programs.
• Partner with Medical Affairs to facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed activities with the goal of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality representatives, and act as the Quality Assurance point person for all GxP matters within the Medical Affairs team and with other related business stakeholders. Drive necessary change and efficiency through provision of effective feedback and recommendations.
• Identify and raise areas of concern where quality gaps have been identified and partner with Medical Affairs leaders to assign tasks to remove those gaps. - Provide operational QA leadership and Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation and the CAPA Management Process for the respective business areas.

Responsibilities:

Leadership and Project Management:

• Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, Data Protection, and other local regulatory requirements throughout the planning and execution of Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies.

• Provide comprehensive quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use or Managed Access Programs.

• Collaborate with the Sr Director, Medical Affairs QA to conduct quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics, including Key Quality Indicators (KQIs). Identify and drive initiatives for continuous quality improvement.

• Deputize for the Sr. Director, Medical Affairs QA as needed.

Cross-functional and Global Team Participation:

• Drive quality excellence through effective business partnerships with stakeholders across functions.

• Provide leadership and guidance on assigned programs, collaborating closely with the Head of Development and Medical Affairs QA to implement the quality strategy and/or quality plan, fostering a culture of quality within Medical Affairs.

• Lead strategic initiatives in collaboration with Medical Affairs stakeholders to uphold the ethical conduct of interventional, non-interventional, investigator-initiated trials, and managed access programs to the highest quality standards.

• Act as the primary QA point of contact for all Medical Affairs programs, collaborating with GxP Quality representatives across the organization

Quality Management and Con