Senior Director - GLP, Biomarkers and Research Quality
Core
Strategic leadership and oversight of end-to-end quality assurance, compliance, and risk-informed quality strategy for clinical evidence generation and product vigilance across research, biomarker development, and diagnostics.
Role type
Senior Director, Quality Assurance & Compliance (Research/GLP/Biomarkers)
Builds
Quality oversight systems and compliance frameworks for pre-clinical, clinical, and diagnostic R&D programs
Domain
Biotechnology / Life Sciences / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic planning, risk management, regulatory compliance (GLP/GCP), vendor governance, data integrity, cross-functional leadership, inspection readiness, industry policy influence
Preferred skills
Experience in AI/automation adoption, external perspective, curiosity, sound judgment
Technologies
None explicitly listed
Responsibilities
Define and execute quality strategy for research, assay development, GLP studies, and IVD; oversee operational quality team to identify and resolve compliance issues; lead inspection readiness activities; chair operational governance meetings; provide strategic direction and mentoring to direct reports; communicate quality insights to business and quality leaders
Seniority
Senior Director, strategic leadership & mentorship
