Accomplished Quality Assurance Manager with deep expertise in ISO 9001, ISO 17025, ISO 13485, ISO 27001 and FDA‑regulated environments. Qualified IRCA CQI Lead Auditor (ISO 27001:2022) with hands‑on experience in GMP and GLP‑compliant laboratory operations and advanced analytical techniques including NMR, IR, LC‑MS, HPLC, GC‑MS. Proven track record designing, implementing, and maintaining robust QMS and ISMS frameworks, conducting internal and external audits, preparing regulatory submissions, and securing market access across multiple jurisdictions. Skilled at translating regulatory requirements into practical SOPs, validation protocols (IQ/OQ), and risk management controls to ensure product safety and compliance.

Demonstrated success delivering quality assurance for high‑risk medical devices and complex products, including readiness for UKAS/ISO 17025 assessments, CE marking, and FDA 510k pathways, and supporting regulatory entries into markets such as Australia and Brazil. Strong communicator and project manager who develops and delivers training, leads cross‑functional teams, and presents audit findings and corrective actions to senior leadership to drive continuous improvement. Technical proficiency in equipment and method validation, OOT/INC reporting, and proficiency testing is complemented by a disciplined, detail‑oriented approach to problem solving and time management. Holds an MChem degree and remains committed to ongoing professional development in chemical science and quality systems.

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