Sunita S.
Site Head Quality Ra Compliance @Texas Biomedical Research Institute
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WORK HISTORY
Site Head Quality Ra Compliance @Texas Biomedical Research Institute
San Antonio, TX, US
Lead Site Quality / Regulatory / Compliance team responsible for the Preclinical, Nonclinical and Clinical operations for highly infectious and rare diseases. GCP, GLP, GMP, GDP environment
EDUCATION
University of Lucknow
Ph.D., Biochemistry and Molecular Biology
University of Lucknow
M.S., Biochemistry and Molecular Biology
University of Lucknow
B.S., Biochemistry, Molecular Biology, Chemistry
ABOUT SUNITA S.
Executive leader with 30+ years of experience in Life-Sciences organizations: R&D, Clinical, Compliance, Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Validation, Audit.Strategic thinking executive experienced in supporting corporate initiatives, Develop high performance teams, Lead a Drive for Compliance Quality Culture, Lead Cross functional Site specific, Regional and Global teams, Collaborate with Medical professionals and Business partners, Employ data-driven hands-on approach to problem solving, Decision making, Passionate in applying excellent organization and communication skills to manage and lead teams in complex projects and develop simplified solutions with value-driven leadership, Achieve low operating costs, and high profitabilityCompetencies:Clinical trials, Pharmaceuticals, Biotech, Medical Device, IVDs CompaniesProduct Life CycleRisk-management regulatory approachAnalytical Data ManagementCompliance quality culture throughout the organizationTechnology Transfer Cost-effective programsMedical Affairs responsibilitiesSpecialties: Strategy Leader, Cost effective & Problem solverClinical trials, research and operationsMedical Affairs operationsFDA and Global RegulationsGxP environmentRegulatory submissions (IND, NDA, BLA, 510K, PMA) Technical OperationsRisk ManagementChange Management
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