Associate Director

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Date: 25 Feb 2025

Location: All Europe, Europe, 81379

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 of Associate Director, Medical Affairs QA.

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.

• 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 for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use Programs, Managed Access Programs, and Investigator-Initiated Studies. This includes the timely escalation of issues, oversight of deviations/incidents and investigations, management of third-party/vendor performance, and serving as a liaison to support audits and inspections as needed.

• Quality Management and Continuous Improvement:

Provide leadership and guidance in the development and execution of Corrective and Preventive Actions (CAPAs), ensuring timely closure, effective checks, and the appropriate escalation of critical issues. Collaborate with QMS QA to ensure the consistent implementation of all relevant Quality Standards within Medical Affairs and identify opportunities for continuous improvement in quality and compliance across the department. Continuously assess and improve quality and compliance with regulations, company standards, policies, and procedures by partnering with stakeholders and QA functions. Provide clear interpretation of regulations, company standards, guidelines, policies, and procedures to personnel, particularly for assigned programs and continuous improvement initiatives. Lead the development, implementation, and proactive management of program-specific quality plans to ensure high standards of quality throughout the lifecycle of each study or program.

• Customer-Focused / Stakeholder Engagement:

Provide quality oversight for strategic initiatives, working closely with Medical Affairs stakeholders to ensure the highest ethical standards and quality in the execution of interventional, non-interventional, investigator-initiated trials, and managed access programs.

• Regulatory Inspection Management and Lessons Learned:

Facilitate the preparation, management, and follow-up of regulatory inspections in close collaboration with business functions, ensuring thorough support for local inspections with robust systems and process resources. Lead the flow of lessons learned from audits, inspections, incidents, regulatory intelligence, and process effectiveness checks, utilizing this information to drive continuous improvement through targeted actions and metrics.

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

• 7 or more years pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in regulated GCP environment required

Profound knowledge of global drug development.

Demonstrated experience of successfully supporting projects of high impact.

Demonstrated agility in a global/matrix environment.

Strong interpersonal skills with demonstrated ability to build collaborative relationships.

Thorough and extensive knowledge of ICH-GCP including FDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance's and current industry practices.

Excellent verbal and written communication skills and computer skills.

Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation.

Capable of working independently as well as part of a cross-functional team demonstrating the ability to influence and create alignment across multiple functional areas.

Flexibility to react to changing priorities in a dynamic business environment.

Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world.

Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients' lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.