Team Lead, Therapeutic Area Quality (GCP / Clinical Quality)
Core
Lead a team of Quality Business Partners to provide independent GCP quality oversight and expert support for clinical trial conduct and R&D programs.
Role type
Senior Team Lead, Clinical Quality (GCP)
Builds
Quality strategy and plans for clinical development programs across therapeutic areas
Domain
Biopharmaceuticals / Clinical Research / Regulatory Quality
Required skills
GCP quality oversight, Risk management, Quality by Design, Regulatory compliance (GLP/GVP), Team leadership, Strategic planning, Root cause analysis, Audit management, Due diligence support, Therapeutic area knowledge (oncology, immunology, respiratory, vaccines)
Preferred skills
Regulatory authority inspection support, Risk-based quality management, AI/ML and data analytics, Multicultural matrix organization navigation
Technologies
Veeva QMS, CTMS
Responsibilities
Drive continuous quality improvements based on risk assessments and audits; Provide input into global audit plans; Ensure submission and inspection readiness; Lead talent development and performance management for the quality team; Support health authority GCP inspections; Participate in in-licensing due diligence activities
Seniority
Senior, hands-on IC with management responsibilities