Senior Director, Development Quality Assurance
Core
Implementing and executing quality assurance strategies to support clinical development activities and ensure compliance with GCP, GLP, GVP, and global regulatory requirements.
Role type
Senior Director, Development Quality Assurance (DQA)
Builds
A fit-for-purpose Quality Management System (QMS) and inspection-ready clinical development programs
Domain
Clinical-stage oncology / Biopharmaceuticals
Deliverable
Dashboards & analysis
Required skills
Quality strategy execution, audit planning and execution, regulatory inspection management, SOP development, vendor/CRO oversight, risk-based decision-making, data-driven insights, training and education
Preferred skills
Artificial Intelligence (AI) and advanced analytics expertise, harmonization of quality processes across organizations
Technologies
None explicitly stated
Responsibilities
Execute DQA objectives and priorities; partner with functional leaders to promote quality culture; lead or oversee internal and external audits of clinical sites, CROs, and vendors; coordinate operational inspection readiness activities for FDA, EMA, and other authorities; lead the development and implementation of Development SOPs and guidance documents; support qualification and ongoing evaluation of CROs and external partners; drive continuous improvement of the enterprise QMS
Seniority
Senior Director, leadership & strategy
