Associate Director, Clinical Quality and Continuous Improvement
Core
Provides strategic QA oversight across clinical development procedures to ensure compliance with GCP requirements, regulatory expectations, and internal quality standards.
Role type
Associate Director, Clinical Quality and Continuous Improvement
Builds
Clinical development processes and quality systems
Domain
Clinical research / Pharmaceutical / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GCP compliance, root cause analysis, process improvement, cross-functional partnership, enterprise issue management, regulatory expectations, quality system design, change management, metrics and trend analysis
Preferred skills
GLP and post-market (PV) domain experience, scalable quality solutions, multi-study issue management
Technologies
None stated
Responsibilities
Represent QA in operational process improvement initiatives; Identify process inefficiencies and implement scalable, standardized solutions; Lead the management, tracking, and documentation of Quality Events (QEs) involving significant quality issues; Drive comprehensive, cross-study issue root cause analysis (RCA) efforts; Establish and maintain mechanisms to measure process adoption, compliance, and effectiveness; Escalate recurring or systemic trends to Clinical Quality Risk & Portfolio Oversight leadership
Seniority
Senior, hands-on IC
