Director, Quality Systems & Compliance
Core
Strategic leadership of Quality Systems and Compliance, evolving the QMS into a digitally enabled, scalable ecosystem supporting clinical through commercial operations.
Role type
Director, Quality Systems & Compliance (Digital System Owner)
Builds
Intelligent, data-driven Quality Management platforms and enterprise digital solutions
Domain
Biopharmaceuticals / Advanced Therapies / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Global GxP regulations expertise, Business System Ownership, Digital transformation leadership, AI/ML in regulated environments, Data integrity (CSV/CSA), Enterprise system management, Operational excellence, Cross-functional influence
Preferred skills
Veeva Vault experience, Advanced analytics, Predictive quality signal detection
Technologies
eQMS, DMS, LMS, SAP, LIMS, MES, Veeva Vault, AI/ML tools
Responsibilities
Lead and continuously improve Quality Systems (Document Management, Training, CAPA, Deviations, Change Control, Risk Management, Supplier Quality, Audit/Inspection Management), Serve as primary host and lead for client audits and regulatory inspections, Drive optimization through automation and native AI capabilities, Act as primary influencer for enterprise-wide adoption of Quality Systems, Serve as primary interface between Quality, IT, and Data/AI teams, Lead the QMS Business System Governance process
Seniority
Director, strategic leadership & cross-functional influence
