An accomplished quality and compliance leader with over 16 years of experience driving complex technological projects, managing teams, and ensuring regulatory compliance in the Tech and Life Sciences industries. Expertise spans across quality management, regulatory adherence, and customer-facing roles, with a proven track record in leading initiatives to meet business objectives.Key competencies include:•Strategic leadership and stakeholder management.•Deep knowledge in AI ISO 42001 certification.•Mastery of international quality regulations (Security ISO 27001 and ISO 27017, Medical Devices ISO 13485, Risk Assessment ISO 14971, CSV/ERES 21 CFR Part 11, Part 820, Annex 11, etc.).•Extensive experience in quality systems, process improvement, and team mentoring across global markets (US, Europe, and offshore teams).•Strong focus on Security and Quality planning, budgeting, and compliance integration into organizational operations (Security. TOM, DPO, Sub-Processing).
Listed skills include Quality Assurance, Fda, Quality System, Medical Devices, and 39 others.