Senior Manager Medical Affairs QA (m/f/d)

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.

Purpose of the function

Senior Manager, Medical Affairs QA provides leadership and strategic direction for assigned programs, ensuring the effective implementation of quality strategies and fostering a quality‑driven culture within Medical Affairs. This role oversees strategic quality initiatives in close collaboration with Medical Affairs stakeholders and serves as the primary QA point of contact for all Medical Affairs programs. Reporting to the Head of Development and Medical Affairs QA, the Senior Manager is responsible for end‑to‑end quality oversight across interventional and non‑interventional studies, investigator‑initiated studies, and managed access or compassionate use programs. This includes ensuring compliance with GCP, GPV, data protection, and applicable local regulatory requirements throughout program planning and execution.

Location

Munich, Germany.

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 for Medical Affairs activities, including interventional studies, non‑interventional studies, compassionate use programs, managed access programs, and investigator‑initiated studies. This includes 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 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.

Education & Experience

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or Medicines.
• Master's degree or other advanced degrees (Preferred).
• Seven or more years of pharmaceutical experience in clinical development and the pharmaceutical industry with involvement in a regulated GCP environment.

Skills and Additional Requirements

• Profound knowledge of global drug development, including extensive expertise in ICH‑GCP, FDA/EU regulations, pharmacovigilance, and current industry practices.
• Proven track record of successfully supporting high‑impact, complex projects.
• Strong project management skills with the ability to prioritize and deliver in dynamic environments.
• Demonstrated ability to work effectively in global, matrix organizations, building collaborative relationships and influencing cross‑functional stakeholders to drive alignment.
• Excellent communication and interpersonal skills, with the ability to convey complex information clearly and effectively.
• Strong problem‑solving, decision‑making, and conflict resolution skills.
• High degree of organizational awareness, with experience navigating cross‑functional teams and diverse global environments.
• Adaptable and flexible, with the ability to respond to changing priorities and business needs.
• Proficient in relevant computer and digital tools.