Peggy Yena

Vice President, Quality & Regulatory Affairs @BioCare, Inc

Phoenix, AZ, US
MOBILE NUMBERS
+16•••••••35

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WORK HISTORY

Dec 2021 — Present

Vice President, Quality & Regulatory Affairs @BioCare, Inc

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EDUCATION

1979 — 1983

Arizona State University

Bachelor of Science (B.S.), Medical Technology

SKILLS

LimsMicrobiologyLife SciencesMolecular BiologyClinical TrialsHipaaTechnical DocumentationGenomicsBioinformaticsCtmsCoagulationTechnical CommunicationResearchClinical ResearchGeneticsLaboratoryToxicologyCancerGcpHealthcare ITHealthcare Information Technology (Hit)OncologyInformaticsBiotechnologyTechnical ManagementStandard Operating Procedure (Sop)Technology ManagementClinical Data ManagementHealthcare Information TechnologyChemistryCancer ResearchProject ManagementHematologyCernerBlood BankLifesciencesPharmaceutical IndustrySopFdaSecurity Management

ABOUT PEGGY YENA

I began my career in a Banner hospital lab. In other words, as an IT executive and VP of Quality Management and Compliance, I am clinically trained but also “speak IT.” Understanding the needs of clinical staff from the inside, what I have been able to do across my career in technology is communicate the importance of IT compliance to clinicians, but also communicate clinical needs to staff in IT and application development / SDLC. Truly, it is a two-way street. What I have found is that “traffic” flows easier when everyone understands one another. Projects are completed on time (even on aggressive implementation schedules). We are able to stick to budgets without going over. And employee engagement / employee satisfaction is a given.Hands-down the best part of my favorite roles have been rooted in collaboration. And it should occur on ALL levels from entry-level technicians to CIO. “If you take out the team in teamwork, it’s just work. Now who wants that?” ― Matthew Woodring Stover. 21 Years of Healthcare IT experience / VP IT Enterprise Compliance and Quality Management / Director of IT 15+ years of experience in Hematology, Pathology, and Departmental Hospital Management Extensive Knowledge & Regulatory Agency Experience: College of American Pathology (CAP) Audits, ISO 15189, CLIA, FDA Inspections, NYS DOH, State Labs, Laboratory, Biorepository, GLP, GMP, GCP, 21 CFR Part 11, 45 CFR Part 164 Subpart C, HIPAA, Sarbanes-Oxley (SOX), and Computer System/Process/Equipment Validation Track record of IT transformations, system implementations, and integrations Direct impact to revenue in excess of $100M Critical player behind strategic IT compliance, CAP accreditation, quality assurance, automation, QAT, and UAT Certified Medical Technologist under American Society for Clinical Pathologists (ASCP) and the National Certification Agency (NCA) with a Specialty in Hematology (SH)Keywords: Vice President of IT Enterprise Compliance, Vice President of IT Quality Assurance, Vice President of Enterprise Applications, Software Development Life Cycle, Quality Assurance Roadmaps, Regulatory Compliance, Data Management, Product Development, R&D, Performance Management, Recruiting & Hiring, Agile & Scrum, Budget Management, IT Project Management, Process Improvements, Patient Safety, SaaS/In-House Development, Cerner EMR / EHR, Sapphire LIMS, OpenClinica CTMS, Reporting & Documentation

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