Director, Quality Assurance
Core
Drives quality performance, regulatory compliance, and inspection readiness across 503A and 503B pharmaceutical operations using AI-enabled analytics.
Role type
Director, Quality Assurance (Pharmaceutical Manufacturing)
Builds
Quality systems, audit programs, supplier quality oversight, and validation activities for FDA-registered outsourcing facilities.
Domain
Healthcare / Pharmaceutical Manufacturing / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP, USP standards, FDA regulations, audit management, supplier quality, validation oversight, CAPA management, risk governance, team leadership, strategic communication
Preferred skills
Digital quality systems implementation, process improvement methodologies, Lean Six Sigma Green Belt, Certified Pharmaceutical Industry Professional (CPIP), Professional Engineer (PE), Certified Quality Engineer (CQE)
Technologies
AI-enabled analytics, predictive monitoring, digital quality systems, workflow automation, AI-powered compliance tools, AI-assisted analytics, AI-enabled dashboards
Responsibilities
Lead Quality Assurance operations ensuring compliance with FDA regulations and cGMP; Direct inspection readiness and response management for audits; Oversee internal audit programs and supplier quality programs; Provide leadership for validation activities; Manage deviations, investigations, CAPAs, and change controls; Establish KPIs to monitor quality performance and compliance trends; Build high-performing quality teams and align quality priorities with executive teams
Seniority
Director, strategic leadership & operational execution
