Elisa Halker

About Elisa Halker

Senior professional, more than 20 years of experience with solid understanding of global clinical development and robust experience on GCP-ICH. Successful track record on quality incident investigations, CAPA management, inspection management, Quality Management System, SOPs, and pragmatic and hands-on approach to problem solving and multi-functional collaboration. Robust background in multi-functional work teams, communication, and training with international experience (Europe, Asia, Latin America, and US), and a successful track record on delivery of quality data under high ethical standards.Expertise• GCP/ICH and applicable authorities’ guidelines• GLP Principles• Inspection Management• QMS principles• Risk assessment• Issue and Deviation Management• Audits responses management and tracking • Corrective and Preventive Actions (CAPAs)• Data Metrics and trends• Clinical Operations Governance and Execution (in & outsourcing)- Phase 1 to 4• Change Management• Clinical Trial Management• SOPs

Experience

1. Senior Director, R & d Quality and Compliance

   Intellia Therapeutics, Inc.

   Dec 2025 — Present · US

Education

• UNIFESP - Universidade Federal de Sao Paulo

  Master's degree, Registered Nursing, Nursing Administration, Nursing Research and Clinical Nursing

  1990 — 1993

• Clinical Trials

  Compliance in Clinical Operations

Skills

• Clinical Trials
• Pharmaceutical Industry
• Gcp
• Clinical Development
• Sop
• CRO
• Ctms
• Ich-Gcp
• Vaccines
• Clinical Research
• Regulatory Affairs
• Oncology
• Clinical Monitoring
• Regulatory Submissions
• Pharmacovigilance
• Biotechnology
• Edc
• Infectious Diseases
• Drug Development
• Clinical Operations
• Standard Operating Procedure (Sop)
• CRO Management
• Electronic Data Capture (Edc)
• Good Clinical Practice (Gcp)
• Clinical Trial Management System (Ctms)