QA Compliance Manager - Clinical Trials
Core
Manage GxP audits and regulatory inspections for the company, investigator sites, and clients, primarily in the APAC region.
Role type
Senior IC QA Compliance Manager (Clinical Trials)
Builds
Compliance assurance for clinical research programs and regulatory submissions
Domain
Life Sciences / Clinical Research / Quality Assurance
Deliverable
client delivery
Required skills
GxP compliance, GCP, quality management systems, root cause analysis, risk assessment, audit facilitation, CAPA development, regulatory framework knowledge
Preferred skills
Management/leadership experience, Veeva QMS, Biology or Pharmacy background
Technologies
Microsoft Office Suite, Veeva QMS
Responsibilities
Provide consultation on audit readiness, lead and review audit reports, support root cause analysis and CAPA implementation, mentor staff, develop compliance tools and guidance documents, present audit findings to stakeholders
Seniority
Senior, hands-on IC with leadership responsibilities
