Quality & Regulatory Compliance leader | LifeSciences Consultant & Advisor | Expert in Digital Transformation of Quality Management Systems and Enterprise System Validations | Inspection Readiness and Audits. A dynamic and results-driven Quality and Regulatory Compliance leader and expert with 19 years of experience across pharmaceutical, biotechnology, and medical device industries, specializing in GxP systems, regulatory intelligence, data governance and digital transformation in highly regulated environments. My expertise spans the full system development lifecycle (SDLC), risk-based Computer System Validation (CSV), emerging Computer Software Assurance (CSA) frameworks, and global data integrity standards (ALCOA+). I lead enterprise-wide implementations of digital platforms like eQMS, LIMS, ERP, MES, and clinical systems (e.g., Veeva, TrackWise, MasterControl, ETQ Reliance, LabWare, SAP, Oracle, Empower LIMS), enabling clients and employers to meet FDA, EMA, and global inspection-readiness standards. As a trusted SME in 21 CFR Part 11, Part 4, Annex 11, ISO 13485, and GAMP 5, I help bridge quality, IT, and regulatory functions through scalable, risk-based validation strategies. In my consulting practice, I support life sciences organizations - from startups to global enterprises, with: - Digital system validation (CSV/CSA) strategy and execution - cGxP system implementation and remediation - Regulatory intelligence, regulatory submissions (510(k), PMA, IDE, IND/NDA), and gap assessments - Inspection readiness, data integrity, and Part 11/Annex 11 compliance audits - Combination products regulatory pathway, post-market processes, complaint handling and governance With specialized expertise in advanced therapeutics and combination products (auto-injectors, pre-filled syringes, and advanced drug-device platforms), I develop and refine scalable processes, trending tools, and cross-functional investigation frameworks. I collaborate across PV, Regulatory, Tech Ops, and Quality to ensure robust root cause analysis, timely CAPAs, and global reporting compliance (QMSR, ISO 14971, EU MDR, etc.). Whether in an internal leadership role or external consulting capacity, I’m passionate about modernizing quality systems, enabling cross-functional digital adoption, and translating complex regulatory requirements into actionable, inspection-ready processes. Let’s connect if you’re looking for a strategic partner in digital quality, validation, or regulatory execution with a global, risk-based mindset and deep experience across the product lifecycle.