Director, Quality Risk Management (QRM), Global QMS, R&D & PV QA
Core
Establish, govern, and advance a global Quality Risk Management (QRM) framework across R&D, Pharmacovigilance, and Medical Affairs to ensure proactive identification, assessment, and control of quality risks in alignment with ICH Q9 (R1) and GxP regulations.
Role type
Director, Quality Risk Management (QRM)
Builds
Global QRM framework, standardized risk assessment methodologies, governance structures, and digital QRM tools/dashboards
Domain
Pharmaceutical/Biotechnology Quality Management System (QMS)
Deliverable
dashboards & analysis
Required skills
Quality Risk Management (QRM), ICH Q9 (R1) and ICH Q10 expertise, GxP compliance, independent QA oversight, regulatory inspection readiness, vendor/third-party risk governance, strategic planning, cross-functional leadership
Preferred skills
Advanced degree (PhD, PharmD, MBA), digital QRM tools experience, risk analytics, training and capability building
Technologies
Digital QRM tools, dashboards, analytics platforms
Responsibilities
Lead design and evolution of global QRM framework; Provide independent QA oversight for risk identification and assessment; Establish governance structures and escalation pathways; Monitor regulatory trends and ensure inspection readiness; Partner with cross-functional stakeholders to embed risk-based thinking; Drive continuous improvement of QRM practices
Seniority
Director, strategic leadership & governance
