Amit N. Patel
Management Consultant | Quality | Regulatory Compliance | Project Management | Data Integrity | Lean Six Sigma Black Belt
- Role
- Senior Quality Assurance Consultant at Independent Consultant
- Location
- Harrisburg, PA, US
- LinkedIn followers
- 500 followers
About Amit N. Patel
Senior Quality and Regulatory Compliance professional with 18+ years of experience across FDA-Regulated Industries. Proven track record leading enterprise Quality Management Systems (QMS), inspection readiness, remediation, and global regulatory compliance.Extensive experience with FDA, EMA, MHRA, and global health authority inspections, including warning letter remediation, consent decree support, and post-inspection CAPA execution. Expert in quality transformation, data integrity, supplier quality management, serialization, and governance of GMP, GxP, and ISO-aligned systems.Led and advised C-Suite / Executive Leadership teams on:• Enterprise QMS design, integration, and remediation• Inspection readiness, regulatory strategy, and agency interactions• Quality operations, risk management, and compliance governance• M&A due diligence, integration, and quality system harmonization• Supplier qualification, packaging compliance, and audit programsKnown for pragmatic leadership, clear executive communication, and the ability to stabilize and scale quality organizations under regulatory and operational pressure.
Experience
Senior Quality Assurance Consultant
Sep 2010 — Present
Education
California State University-Dominguez Hills
Technical Writing Certificate, Technical Writing
Nirma University
Bachelor of Pharmacy (Hons.), Clinical Pharmacy
California State University-Dominguez Hills
Master of Science - MS, Quality Assurance
Villanova University
Masters Black Belt Certificate in Six Sigma, Six Sigma Green Belt, Lean Six Sigma, Six Sigma Black Belt
University of Chicago
Medical Writing and Editing Certificate, Medical Editing
Amravati University
Bachelor of Pharmacy, Pharmaceutical Sciences
Skills
- Microbiology
- Computer System Validation
- Investigations
- Analytical Chemistry
- Cleaning Validation
- Mdr
- Standard Operating Procedure (Sop)
- Software Documentation
- Complaint Investigations
- Root Cause Analysis
- Capa
- Gamp
- Inspection
- Gcp
- Biopharmaceuticals
- Process Validation
- Regulatory Submissions
- Compliance
- Glp
- Quality Assurance
- Corrective and Preventive Action (Capa)
- Cgmp
- 21 Cfr Part 11
- Technical Writing
- Technology Transfer
- Quality Control
- Gmp
- Quality Management
- Remedial Investigations
- Trackwise
- Regulatory Affairs
- Validation
- Lims
- Hplc
- Quality System
- Quality Systems
- V&V
- Private Investigations
- Document Review
- Biotechnology
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