Senior Director, Global Clinical Supply Quality Assurance

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.

Job Summary The Senior Director, Quality Assurance, Global Clinical Supply is responsible for establishing and leading the global quality strategy for clinical trial materials across all phases of development. This role ensures compliance with global regulatory requirements, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP), while driving quality excellence throughout the CTM lifecycle—from manufacturing and packaging to distribution and use in clinical trials.

Responsibilities Strategic Leadership & Oversight and Cross-Functional Team Participation:

Cross-Functional Team Participation:
Develop, lead, participate or manage resources that support various working groups Responsible to contribute to the achievement of global QA vision and enhance globalization at DS QA-GMP affiliates, proactively support and contribute to the development and execution of regional and global QA GMP strategies, internal and external collaboration, activities and initiatives that support and drive compliance and improvement opportunities for IMP, new and established products;
Ensure a strong interface with Pharmaceutical Technical Development, CSO, RACMC to ensure full QA visibility and proactive engagement of QA across stakeholder

Responsible for providing strategic QA GMP leadership and oversight for clinical trial material (CTM) lifecycle management (e.g. supplier and material management, labeling, shelf-life management, packaging, distribution, and destruction) to ensure investigational products are safe, consistent, and traceable.

Development of Standards and Procedures (SOPs):
Liaise with GMP Quality Systems function to ensure adequate procedural documents directly impacting area of responsible and/ or other GMP areas as assigned. May lead and/ or direct key global/regional QA GMP Standards, Procedures and Instructions. Develop, implement, and maintain a global CTM quality assurance program aligned with organizational and regulatory expectations.

Partner closely with relevant stakeholders across various departments (includes but not limited to clinical supply chain, clinical operations, regulatory, R&D QA, and GMP QA) responsible for various activities in the management of clinical trial materials.

Establish strong working relationships with Clinical Supplies Organization (CSO) to ensure clinical forecasts reflect shared, achievable targets for QA GMP and align with the broader clinical development plans.

Serve as the subject matter expert (SME) for CTM quality across regions.

May represent QA GMP Head in leadership meetings to communicate, deliver and / or execute the vision and strategy of GMP-QA organization. Communicate clearly and in a timely manner with Regional and Global QA organization and local leaders of DS QA-GMP affiliates to address and identify proactive solution for business contribution, ability to effectively manage conflict with diplomacy. Ensure effective influential skills to support the vision and strategy of Global QA mission across boundaries and with different stakeholders.

Directs and oversees the local process for investigation of commercial and investigational drug product complaints. Assures that all…