Nita Shah
Fda Strategy Auditor Consultant @Harbor Clinical
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WORK HISTORY
Fda Strategy Auditor Consultant @Harbor Clinical
Conduct comprehensive GMP and GCP audits across various manufacturing and clinical phases, including vendor, sponsor, and system audits.• Develop risk-based audit strategies for global manufacturing and clinical operations.• Provide expert guidance on GMP and GCP compliance to cross-functional teams.
EDUCATION
Kean University
Biotechnology
ABOUT NITA SHAH
Executive per Quality Assurance, Compliance & Regulatory Strategy | QP | Global GxP Expert (GMP, GCP, GLP, GDP, DEA)| FDA & EMA Advisor | Senior Auditor | Pharma | Biotech | Medical Devices | Open to FTE & ConsultingQuality Assurance and Regulatory Affairs Executive with 25+ years of experience across 43 countries and 163+ product types, supporting pharmaceutical, biotech, and medical device companies at every stage of the product lifecycle. I lead global quality and compliance programs that align with FDA, EMA, MHRA, Health Canada, and APAC regulatory expectations—delivering scalable, inspection-ready systems and risk-based solutions.As a Qualified Person (QP) and Senior Auditor, I bring deep expertise across GxP (GMP, GCP, GLP, GDP, DEA) with a proven track record in FDA strategy, global audits, and regulatory submissions. I’ve supported regulatory filings (IND, NDA, BLA, CTA, MAA), managed mock inspections and remediation, and led inspection readiness initiatives for high-priority programs.My experience includes combination products, sterile manufacturing, aseptic processing, advanced therapy medicinal products (ATMPs), gene and cell therapies, oncology, biosimilars, and complex medical devices. Whether leading quality operations for a multinational or acting as a strategic consultant for fast-scaling startups, I bring practical, compliance-driven solutions that meet global regulatory expectations.I’ve worked with cross-functional teams, CMOs, CROs, and global sponsors to strengthen QMS frameworks, ensure clinical quality oversight, and support successful inspections by FDA, EMA, MHRA, and other global authorities.Currently open to executive consulting, interim leadership, and senior full-time roles across QA, Compliance, and Regulatory Strategy.Let’s connect if you\'re seeking a trusted QA/RA leader to support global regulatory success, inspection readiness, and sustainable quality systems.
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