Linda Buchanan
- Role
- Director Quality, Gcp, Glp & Gvp at Vor Bio
- Location
- Levittown, PA, US
- LinkedIn followers
- 500 followers
About Linda Buchanan
I am a results-driven Clinical Quality Assurance professional with a proven track record in clinical research, biotechnology, and gene therapy. I apply advanced knowledge of international regulations and industry guidelines (ICH-GCP, GVP, GcLP, and FDA requirements) to monitor and elevate quality standards across global clinical programs. I Lead comprehensive audit initiatives, steer CAPA lifecycle management, and enforce solution-oriented quality enhancements to ensure full compliance. I facilitate cross-departmental collaboration to maintain data accuracy and prioritize patient well-being. I direct strategic audit scheduling and hands-on execution, uncovers root causes of compliance gaps, and crafts actionable solutions to minimize risk. I elevate operational performance through strong governance practices and ensures preparedness for regulatory authority inspections. I am recognized for precision, strong analytical thinking, and clear, bilingual communication in both English and Spanish. Core Competencies: • Health Authority Inspection Hosting (FDA, MHRA, EMA) • Risk Assessment • GCP/GcLP/GVP Regulatory Compliance • Audit Planning and Execution • Vendor, Document and Investigator Site Auditing • SOP Development • Clinical Research • Quality Management Systems (QMS) • Biotech, Gene Therapy
Experience
Director Quality, Gcp, Glp & Gvp
Sep 2025 — Present · Levittown, PA, US
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