Senior Director, Quality Systems/QMS
Core
Strategic leadership of the Global Quality Management System (QMS) to ensure integrity, effectiveness, and alignment with global regulatory expectations across GxP domains.
Role type
Senior Director, Quality Systems
Builds
Global QMS framework, governance models, and strategic roadmap for emerging technologies and modalities
Domain
Biotechnology / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic leadership, GxP operational oversight, regulatory compliance expertise, risk management, change management, enterprise partnership, cross-functional stakeholder influence, quality culture advocacy, team mentorship, root cause analysis, Lean/Six Sigma methodologies, data analysis
Preferred skills
Experience in sponsor or contract organization QA leadership, preclinical/clinical/CMC process knowledge, digital enablement readiness
Technologies
None explicitly listed beyond general digital enablement concepts
Responsibilities
Provide strategic vision and oversight for the global QMS across GxP domains; Lead a team of Quality Systems Owners for specific system areas; Drive systematic risk identification and continuous improvement; Partner with enterprise functions for inspection readiness and strategic planning; Mentor quality professionals to scale organizational capabilities
Seniority
Senior Director, strategic leadership & enterprise oversight