Neha Shah

About Neha Shah

Clinical Quality Assurance, GCP oriented and dedicated professional with extensive experience in Clinical Quality Assurance (QA), investigator site & vendor GCP audits, Research & Development and Validation. Expertise in Clinical QA inspection/audits, root cause analysis, CAPA and non-conformance, SME in Qualification/Validation (IQ/OQ/PQ), validation of computer systems, software upgrades and analytical methods while ensuring compliance with Standard Operating Procedures (SOPs), current Good Clinical Practice (cGCP) and current Good Laboratory Practice (cGLP) regulations.

Experience

1. Associate Director, Clinical Gcp Quality

   Aura Biosciences

   Aug 2025 — Present · Boston, MA, US

   Provide GCP compliance guidance and support to Clinical Operations and cross-functional teams; review and provide feedback on protocols, IB, ICFs, CSRs, monitoring plans, and other study-specific documents.• Partner with Clinical Operations on assigned studies to deliver proactive, risk-based GCP compliance support.• Support the development, quality review, and implementation of GCP/GLP-related policies, procedures, and controlled documents, providing subject-matter expertise as needed.• Develop and maintain the GCP/GLP Annual Audit Plan and managed the Approved Vendor List.• Conduct qualification and routine audits of external vendors supporting clinical trials; author clear, comprehensive audit reports, track responses, and evaluate the adequacy of CAPAs.• Perform internal audits of systems and functional areas to ensure compliance with internal processes, study specific plans, and applicable regulatory requirements.• Support departmental metrics and present compliance data during Quality Management Reviews (QMRs).• Collaborate with Nonclinical/Toxicology teams to identify process gaps and support the development and enhancement of function-specific procedures.• Contribute to the development and execution of the Inspection Readiness program by delivering training, raising compliance awareness, and supporting senior staff during regulatory inspections.

Education

• Kean University

  Bachelor of Science - BS, Medical Technology with Minor in Biology

  1992 — 1996

Skills

• Healthcare
• Document Review
• 21 Cfr Part 11
• Standard Operating Procedure (Sop)
• Coagulation
• Good Laboratory Practice (Glp)
• U.s. Title 21 Cfr Part 11 Regulation
• Pharmaceutical Industry
• Sop
• Fda
• Drug Safety
• Pharmaceutical Research
• Validation
• Assay Development
• Resourceful Problem-Solving
• Protocol
• Clinical Trials
• Clinical Research
• Fda Gmp
• Laboratory
• Gcp
• Hematology
• Glp
• Protein Chemistry
• Multi Tasking
• Study Reports
• Quality Control
• Protocol Review
• Computer System Validation
• Equipment Qualification
• Quality Assurance
• Chemistry
• Research
• Good Clinical Practice (Gcp)
• Instrument Validation
• U.s. Food and Drug Administration (Fda)
• Method Development
• Compliance
• Toxicology