Global CTM Quality Assurance Director

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

Job summary

Daiichi Sankyo, Inc. is seeking a Senior Director of Quality Assurance, Global Clinical Supply, to establish and lead the global QA strategy for clinical trial materials across all development phases.

You will ensure GMP/GCP compliance, maintain inspection readiness, and drive QA excellence across CTM lifecycle—from manufacturing to distribution and use in trials. Travel up to 20% is required.

Qualifications

• Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, or related field is required.
• 10+ years of professional experience in Quality Assurance within biotech or pharmaceutical environments.
• Strong experience supporting clinical trial materials and clinical supply chains.
• Travel up to 20% of the time.

Responsibilities

• Cross-Functional Team Participation: develop, lead, or manage resources to support working groups and global QA strategies across DS QA-GMP affiliates.
• Provide strategic QA GMP leadership for CTM lifecycle management including supplier/material management, labeling, shelf-life, packaging, distribution, and destruction.
• Develop, implement, and maintain a global CTM quality assurance program aligned with regulatory expectations.
• Partner with clinical supply chain, clinical operations, regulatory, R&D QA and GMP QA to manage CTM activities.
• Establish relationships with CSO to align QA GMP targets with development plans.
• Serve as SME for CTM quality across regions and communicate QA visions to leadership.
• Lead investigation of complaints and ensure recalls are managed per GMP and SOPs.
• Maintain inspection readiness and respond to regulatory inspections and audits.
• Oversee quality systems related to CTM such as deviations, CAPA, change control, risk management.

Skills

Quality Assurance

GMP/GCP

Clinical Supply Chain

Cross-functional Leadership

Education

Bachelor's Degree in Life Sciences/Pharmacy/Chemistry

Advanced degree (MS/PhD/ PharmD) preferred

Job description

Daiichi Sankyo, Inc. is seeking a Senior Director of Quality Assurance, Global Clinical Supply, to establish and lead the global QA strategy for clinical trial materials across all development phases.

You will ensure GMP/GCP compliance, maintain inspection readiness, and drive QA excellence across CTM lifecycle—from manufacturing to distribution and use in trials. Travel up to 20% is required.