Director, Clinical Quality Risk & Portfolio Oversight
Core
Leads enterprise-wide quality intelligence, portfolio risk surveillance, and centralized quality oversight across Clinical Development to shift from study-level to proactive, enterprise-wide quality risk management.
Role type
Director, Clinical Quality Risk & Portfolio Oversight
Builds
Enterprise quality risk frameworks, portfolio-level dashboards, and vendor quality oversight systems
Domain
Clinical Research / Pharmaceutical R&D / Quality Assurance
Deliverable
dashboards & analysis
Required skills
Enterprise risk management, data analytics, trend analysis, vendor quality governance, compliance monitoring, strategic planning, cross-functional leadership, quality metrics interpretation, regulatory inspection readiness
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead enterprise-level quality surveillance activities across the clinical development portfolio; Identify systemic quality risks, recurring compliance signals, and emerging operational vulnerabilities; Analyze data from audits, inspections, CAPAs, deviations, site and central monitoring activities, vendor oversight, and quality metrics to identify trends and risk patterns; Establish and maintain proactive quality risk detection, escalation, and mitigation frameworks; Develop and maintain portfolio-level dashboards, analytics, and governance reporting to support quality oversight and leadership visibility; Use data analytics to drive trend analysis across studies, functions, vendors, and systems to identify systemic/enterprise compliance concerns, opportunities for improvement, and emerging risks; Translate complex quality data into actionable insights and recommendations for leadership; Define and maintain meaningful risk indicators, thresholds, and escalation criteria; Leads strategic oversight of clinical vendor quality management and establishes scalable oversight framework
Seniority
Director, strategic leadership & team management
