Senior Director, Global Clinical Supply QA & Compliance

Daiichi Sankyo Brasil Farmacêutica; Basking Ridge (NJ); On-site; USD 210,000 - 350,000; Full time

Job summary

Daiichi Sankyo, Inc. in the United States seeks a Senior Director, Global Clinical Supply Quality Assurance to establish and lead the global quality strategy for clinical trial materials across all development phases.

This role ensures GMP/GCP compliance and quality excellence from manufacturing through distribution. The successful candidate will partner with Clinical Supplies Organization, Regulatory, and R&D QA to manage CTM lifecycle, supplier oversight, and regulatory readiness across global

Qualifications

• Bachelor's degree is required in Life Sciences, Pharmacy, Chemistry, or a related field.
• Strong experience supporting clinical trial materials and clinical supply chains.
• Ability to operate independently and build systems from the ground up.
• Experience working in a matrixed environment is required.

Responsibilities

• Lead global CTM quality assurance program across all phases of development.
• Ensure GMP and GCP compliance for CTM lifecycle from manufacturing to distribution.
• Develop and maintain QA standards, deviations, CAPA, and change controls.
• Oversee regulatory readiness and inspection responses for CTM activities.

Skills

Clinical QA experience

Independent work

Matrix environment

Education

Bachelor's Degree in Life Sciences/Pharmacy/Chemistry or related field

Job description

Daiichi Sankyo, Inc. in the United States seeks a Senior Director, Global Clinical Supply Quality Assurance to establish and lead the global quality strategy for clinical trial materials across all development phases.

This role ensures GMP/GCP compliance and quality excellence from manufacturing through distribution. The successful candidate will partner with Clinical Supplies Organization, Regulatory, and R&D QA to manage CTM lifecycle, supplier oversight, and regulatory readiness across global