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, product vigilance, and regulatory expectations across research, biomarker development, and diagnostics.
Role type
Senior Director, Quality Assurance & Compliance (Research/GLP/Biomarkers)
Builds
Quality oversight systems and compliance strategies for pre-clinical, clinical, and diagnostic research programs.
Domain
Biotechnology / Life Sciences / Regulatory Compliance
Required skills
Strategic planning, Risk management, Regulatory compliance (GLP/GCP), Vendor governance, Data integrity, Cross-functional leadership, Inspection readiness, Quality improvement methodologies, Stakeholder management, Mentoring
Preferred skills
Industry forum participation, Policy development influence, New regulatory requirement implementation
Technologies
GLP systems, Quality management systems, Regulatory databases
Responsibilities
Define and oversee strategic quality plans for research, assay development, GLP studies, and IVD; Ensure compliance with good scientific practices and regulatory requirements; Lead operational quality teams to identify and resolve compliance issues; Oversee inspection readiness and governance meetings; Provide strategic direction and mentoring to direct reports.
Seniority
Senior Director, strategic leadership & mentorship
