Professional Profile: Quality and Regulatory Consulting Life Sciences and Health Care.A life sciences and healthcare Digital transformation leader in the IT Quality and GxP compliance space. Extensive experience in developing and executing business and risk strategies that promote and accelerate digitization at a global level. Lead a high performing team to design solutions that help clients innovate and drive automation initiatives. A trusted partner to achieve strategic and operational objectives, process excellence and sustainable regulatory compliance across various technologies.Expertise in Quality Assurance and Regulatory Compliance consultancy at Life Sciences & Health Care (LSHC) Fortune 500 organizations – FDA 21 CFR part 11, 820, and EU directives/Annex 11, MHRA and ISO 13485 through Computerized System Validation (CSV) across ERP, Argus Safety, LIMS, Salesforce.com. Developing Health Care solutions to create new strategies in adapting to changing CMS Regulatory requirements to mitigate financial and operational risks through remediation support on Medical Necessity, ICD 10, CDE (Clinical Documentation Excellence) and Meaningful Use. Proven track record in building and leading GxP regulatory teams, offshore strategy, roadmap, and operational planning to create high revenue client portfolios serving global clients. Focused on team development and continuous improvement for operational excellence. Expanded consulting footprint in top pharma, biotechnology and medical devices clients. Institutionalized industry best practices, created process suite compliant to ISPE GAMP. Achieved SEI CMMI Level 5 (Functional Area Representative & Assessment Team Member), SEI CMM Level 5, and ISO 9001:2008 to address key regulatory, business and technological risks. Certified ISO Lead Auditor, conducted first party audits; front - ended supplier and client audits . Certified Six Sigma Black Belt drove project improvements resulting in measurable and quantifiable financial returns.Conferences: ISPE: Annual Europe Conf. Dublin Ireland 2018 HCCA : Compliance Institute Conf. Orlando USA 2015 ; SAP (India): Presented a paper on Integrated Regulatory Compliance - Compliant Manufacturing for Pharmaceuticals. India 2014;CBI: Annual Forum on Sunshine &Aggregate Spend Conf. Washington DC USA 2012; Paper on Women in IT - Women in Nation Building; Seminar for Women in Hyderabad 2009; ISPE: Engineering Regulatory Compliance GAMP 5.0 Conf. Washington DC USA 2008