Global CTM Quality Assurance Director

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

Job summary

Daiichi Sankyo is seeking a Senior Director of Quality Assurance, Global Clinical Supply, to establish and lead the global quality strategy for clinical trial materials across all development phases. You will ensure GMP and GCP compliance while driving quality excellence from manufacturing to distribution in clinical trials.

Responsibilities include leading QA GMP for CTM lifecycle, developing global QA standards, and partnering with CSO, regulatory, and R&D QA to align with regulatory

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or related field. Advanced degree preferred.
• 10+ years of QA experience in biotech or pharmaceutical environments.
• Strong experience with clinical trial materials and supply chains.
• Ability to travel up to 20% of the time.

Responsibilities

• Lead global QA strategy for CTM across all development phases.
• Provide strategic QA GMP leadership for CTM lifecycle management (supplier, labeling, shelf-life, packaging, distribution).
• Develop, implement, and maintain CTM QA programs aligned with regulatory expectations.

Skills

Quality assurance leadership

Regulatory compliance

GMP/GDP knowledge

Cross-functional collaboration

Audit and inspection readiness

Education

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

MS/PhD/ PharmD preferred

Job description

Daiichi Sankyo is seeking a Senior Director of Quality Assurance, Global Clinical Supply, to establish and lead the global quality strategy for clinical trial materials across all development phases. You will ensure GMP and GCP compliance while driving quality excellence from manufacturing to distribution in clinical trials.

Responsibilities include leading QA GMP for CTM lifecycle, developing global QA standards, and partnering with CSO, regulatory, and R&D QA to align with regulatory