Company
Biotech
Director/SeniorDirector,GCPQualityAssuranceLead
“Director / Senior Director, GCP Quality Assurance Lead. Skills: GCP Quality Assurance, Regulatory inspections, Quality Management System. Lead GCP quality activities. Ensure study compliance”
Industry & Context.
Occasional international travel
What You'll Do.
Lead GCP quality activities
Ensure study compliance
Serve as quality partner
Support protocol review
Manage quality oversight
Ensure alignment on standards
Direct inspection readiness
Support regulatory inspections
Maintain oversight of eTMF
Maintain oversight of protocol deviations
Maintain oversight of non-conformances
Maintain oversight of CAPA
Maintain oversight of quality metrics
Maintain oversight of KPIs
Review audit findings
Ensure remediation activities
Provide quality expertise
Provide quality oversight
Contribute to QMS development
Contribute to QMS improvement
Represent Quality Assurance
Promote quality culture
Mentor quality team members
Develop quality team members
How You'll Work.
Team & Collaboration
Cross-functional teams; Governance forums
Communication Scope
Translate requirements
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