Company
Biotech
Director/SeniorDirector,GCPQualityAssuranceLead
“Director / Senior Director, GCP Quality Assurance Lead. Skills: GCP Quality Assurance, Regulatory Inspections, Quality Management Systems. Lead GCP quality oversight for clinical trials. Serve as QA interface for CROs and external”
Industry & Context.
Occasional international travel
What They're Looking For.
Must Have
Bachelor’s degree or higher in life sciences, pharmacy, or related advanced degree, 10+ years of GCP Quality Assurance experience, Minimum 3 years of leadership experience in a director or senior QA role, Expertise across GCP, GVP, and GLP frameworks, Hands-on audit and inspection experience, Deep knowledge of global regulatory requirements, Proven track record of successfully leading regulatory inspections, Experience developing or significantly enhancing Quality Management Systems
Nice to Have
MSc, PharmD, Experience in biotech or clinical-stage organizations, Experience in neurology, rare diseases, or neurodegenerative clinical programs is a plus
What You'll Do.
Lead GCP quality oversight for clinical trials
Serve as QA interface for CROs and external
Oversee inspection readiness activities
Lead regulatory inspections
Manage quality systems
and improve quality metrics
Conduct audits of clinical sites
Conduct audits of vendors
Conduct audits of CROs
Provide QA leadership for GVP activities
Provide QA leadership for GLP activities
Contribute to Quality Management System development
Promote culture of proactive quality
Promote culture of compliance
How You'll Work.
Team & Collaboration
Cross-functional teams; Senior stakeholders
Communication Scope
Executive reporting
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