Associate Director (m/f/x) Medical Affairs QA

 

Passion for Innovation. Compassion for Patients.

 

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.

In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.

In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.

Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.

 

 

For our Global QA Team we are seeking highly qualified candidates to fill the position 

Associate Director (m/f/x) Medical Affairs QA

Purpose of the function

The Associate Director, Medical Affairs QA will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality strategy and/or quality plans to foster a quality-driven culture within Medical Affairs. The role will involve providing oversight on strategic initiatives in close collaboration with Medical Affairs stakeholders, ensuring the highest ethical standards and quality in interventional, non-interventional, investigator-initiated trials, and managed access programs. This position will report to the Head of Medical Affairs QA.The Associate Director will lead the review of quality and compliance topics, including Key Quality Indicators (KQIs) at Quality Governance Meetings. In close alignment with DS QA teams (DSJ, DSI, DSE, DSBR), they will proactively identify risks and opportunities for continuous improvement. This role will drive end-to-end quality execution across programs, ensuring adherence to GCP, GPV, Data Protection, and local regulatory requirements in the planning and execution of Interventional, Non-interventional, Managed Access Programs, and Investigator-Initiated Studies.The role will involve collaborating with GxP Quality representatives, serving as the primary QA point of contact for all Medical Affairs programs. The Associate Director will support quality oversight for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use or Managed Access Programs, and Investigator-Initiated Studies. This includes timely escalation of issues, oversight of deviations/incidents and investigations, third-party/vendor oversight, and liaising to support audits and inspections as applicable. The Associate Director will provide leadership in developing and executing Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and appropriate escalation of critical issues.In this role, the Associate Director will facilitate regulatory inspection preparation, management, and follow-up in close collaboration with cross-functional teams. They will support local inspections by providing necessary systems and process support and partner with QMS QA to ensure the consistent implementation of all applicable Quality Standards within Medical Affairs. Additionally, they will identify continuous improvement initiatives for quality and compliance areas within Medical Affairs.The Associate Director will identify opportunities to continuously improve quality and compliance with regulations, company standards, policies, and procedures through partnerships with stakeholders and QA functions. They will lead the flow of lessons learned from audits, inspections, incidents, regulatory intelligence, and effectiveness checks on process implementations and metrics. This role will provide expert interpretation of regulations, company standards, guidelines, policies, and procedures to personnel, particularly for assigned programs and continuous improvement projects. The Associate Director will champion, develop, and drive the implementation of program-specific quality plans to ensure proactive management of quality across the program lifecycle.

Roles and Responsibilities

• Leadership and Project Management:

Drive end-to-end quality execution across programs, ensuring compliance with GCP, GPV, Data Protection, and other local regulations throughout the planning and execution of Interventional, Non-interventional, Managed Access Programs, and Investigator-Initiated Studies.Provide comprehensive quality oversight