Kelly Seto
Associate Director, Compliance Biosamples @AstraZeneca
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WORK HISTORY
Associate Director, Compliance Biosamples @AstraZeneca
Mississauga, ON, CA
Collaborate with acquired companies to align their activities and processes related to Human Biological Samples (HBS) with AstraZeneca\'s standards and practices- Manage HBS processes to ensure adherence to standards and consistent application of compliance requirements- Ensure stakeholders are informed of regulatory changes associated with HBS- Provide the business with expert advice and decision-making support for compliant HBS use- Identify and document risks arising from HBS due diligence activities- Support efforts to access new HBS sources while ensuring AstraZeneca\'s compliance with regulations- Act as a subject matter expert by reviewing informed consents, making recommendations on HBS usage, and conducting audits to ensure compliant use of clinical HBS.
EDUCATION
McMaster University
Bachelor of Science - BS
University of Toronto
Doctor of Philosophy - PhD
SKILLS
ABOUT KELLY SETO
I bring extensive expertise in compliance, R&D leadership, and product development. Currently serving as the Associate Director of Compliance Biosamples at AstraZeneca, I focus on aligning acquired companies with our Human Biological Samples (HBS) standards and managing compliance processes to ensure regulatory adherence. I offer expert guidance to aid informed decision-making and facilitate access to new HBS sources. Previously, as the R&D Group Leader at Angle Biosciences Inc, I managed global collaborations, optimized resource use, and ensured quality standards were met, spearheading innovations in molecular assay development that led to a patent and significant business successes. My career is distinguished by building and leading high-performing R&D teams and developing strategic processes to achieve company goals. Specialties: leadership, stakeholder management, biomedical research, biotechnology, pharmaceutical, oncology, HBS management, circulating tumor cells, genetics, molecular biology, compliance, project development, quality assurance, science outreach
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