Senior Clinical Quality Compliance and Policy Leader
Core
Champion a proactive, risk-based quality culture as a GCP quality advisor to early-stage clinical trial study teams and external partners, embedding quality by design across Early Development programs.
Role type
Senior IC clinical quality compliance leader
Builds
Early Clinical Development (ECD) clinical programs
Domain
Pharmaceutical drug development / Clinical Research
Required skills
GCP, ICH guidelines, global regulatory frameworks, root cause analysis, deviation management, CAPA planning, QMS activities, document management, cross-functional collaboration
Preferred skills
Early Clinical Development (ECD) or first-in-human trial experience, Health Authority inspection preparedness, vendor/CRO quality oversight, QMS processes, professional certifications (RQAP-GCP, RAC, SQA)
Technologies
QMS systems, document management tools
Responsibilities
Develop strategic partnerships with cross-functional teams and external vendors; Provide expert GCP quality guidance and risk-mitigation strategies; Support or lead Quality Management System (QMS) activities; Embed quality principles through compliance communications and training; Collaborate on quality compliance checks and desktop assessments; Guide study teams through root cause analysis and CAPA plan development
Seniority
Senior, hands-on IC