Manager, Medical Affairs Quality, RD PV QA

Job Summary

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.

• Promote end‑to‑end, comprehensive quality execution across assigned programs, ensuring GCP, GVP, Data Protection, and local requirements are integrated into the planning and conduct of Interventional, Non‑interventional, Compassionate Use Managed Access Programs, and Investigator‑Initiated Studies.
• Provide operational quality oversight for Medical Affairs activities, including timely escalation of incidents/issues, monitoring deviations/incidents, supporting investigations, and coordinating with third‑party vendors.
• Serve as a key liaison to support audits and inspections as applicable.
• Participate in the review of quality and compliance topics, including KQI, at Quality Governance Meetings, in close alignment with DS QA teams (DSJ, DSI, DSE, DS ) to proactively identify potential risks and opportunities for continuous improvement.
• Provide quality oversight and uphold the ethical conduct of interventional, non‑interventional, investigator‑initiated trials and managed access programs to the highest quality standards in close collaboration with Medical Affairs stakeholders.
• Collaborate with GxP Quality representatives and act as QA point person for all Medical Affairs programs.
• Provide guidance during the development and execution of CAPAs, including tracking of timely closure, effectiveness checks, and escalation of critical issues.
• Partner with QMS QA to ensure aligned implementation of applicable Quality Standards in Medical Affairs and identify appropriate continuous improvement initiatives.
• Provide interpretation of regulations and company process standards, guidelines, policies, and procedures for assigned programs or improvement projects.
• Champion and help implement study/program‑specific quality plans to ensure proactive management of quality.
• Work in close collaboration with Medical Affairs stakeholders to uphold ethical conduct and enhance compliance and quality standards across programs; share lessons learned and contribute to a quality mindset within Medical Affairs.
• Collaborates with QA line functions and Medical Affairs stakeholders to improve compliance and quality standards. Acts as a QA point person for assigned programs.
• Facilitate regulatory inspection preparation, management, and follow‑up in collaboration with business functions; support local inspections with adequate systems and process support.
• Contribute to lessons‑learned information flow based on audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics.

• Bachelor's Degree in Life Sciences, Pharmacy or Medicines required.
• Master's Degree or other advanced degree preferred.

• 4 or more years; minimum of 5 years of experience in the pharmaceutical industry, preferably in clinical development or Medical Affairs, with exposure to regulated GCP environments required.
• Profound knowledge of global drug development processes and regulations, including ICH‑GCP, FDA/EU requirements, pharmacovigilance, and current industry practices preferred.
• Ability to interpret and apply complex regulations, standards, and policies to operational activities preferred.
• Experience supporting regulatory inspections and audits.
• Demonstrated initiative in identifying and implementing process improvements.
• Demonstrated experience supporting high‑impact projects in a matrixed, global environment.
• Strong interpersonal skills with the ability to build collaborative relationships across functions and geographies.
• Excellent project management skills, including the ability…