Zach Sexton Email and Phone Number
South Jordan, UT, US
Zach Sexton's Location
South Jordan, Utah, United States, United States
Zach Sexton's Contact Details
Zach Sexton work email
- Valid
- Valid
- Valid
- Valid
Zach Sexton personal email
n/a
About Zach Sexton
Quality leader and consultant with experience in the medical device (Neurophys, vascular access, IVD, combination), Pharma/ClinOps, Healthcare Data and Consumer Goods industries with expertise in Quality System Development/Evaluation, Risk Management, QSR/ISO/GxP auditing, Computer System Validation, Supplier Quality, CAPA/Complaint/NCMR Management, Design for Quality, Design/Process V&V, Statistical Analysis and Continuous Improvement. Credentials: M.S. Quality Assurance; B.S. Microbiology; ASQ CQE, CQA, CMDA; Six-sigma Green Belt.
Zach Sexton's Current Company Details
Onestudyteam
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Director of Quality and GxP Compliance
South Jordan, UT, US
- Website:
- onestudyteam.com
- Employees:
- 196
Zach Sexton Work Experience Details
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Director Of Quality And Gxp ComplianceOnestudyteamSouth Jordan, Ut, Us
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Director Of Quality & Gxp ComplianceOnestudyteam Aug 2023 - PresentBoston, Ma, Us
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Associate Director Of Quality AssuranceJavara Jan 2023 - Aug 2023Winston-Salem, North Carolina, Us• Developed and implemented an enterprise-wide Quality Management System (QMS) to promote overall quality and consistency in business operations and clinical trial activities.• Administered and supported QMS technology tools, ensuring data integrity and compliance with GCP, ICH, and FDA requirements.• Ensured clinical trials were performed in accordance with applicable study protocols and global regulations through internal audits.• Assisted clinical operations staff with development of risk and CAPA plans.• Partnered with sponsor and CRO quality assurance teams to ensure quality management plans were implemented and being followed, while overseeing the QA team's preparation for internal and external audits.• Oversaw team responsible for monitoring regulatory files/documentation and conducting vendor audits.• Developed and maintained GCP/ICH/FDA compliant procedures and processes, identified key quality metrics, and provided feedback for continuous improvement of clinical trial activities and overall company operations. -
Senior Manager Quality ManagementHealth Catalyst Mar 2021 - Jan 2023South Jordan, Utah, Us• Provide strategic guidance to organization on vendor selection and qualification, working with Legal, Purchasing and Operations.• Build and implement a 13485/820 compliant SaaS & data analytics quality management system, including authoring of policies and providing training for employees and leadership• eQMS/eDMS deployment and administration• Project management, including managing internal and vendor quality and compliance• Development of short-range and long-range operational objectives• Establish Quality Agreements and monitor compliance for Data Quality• CAPA/Nonconformance Management, leading root cause analysis• Coach/Mentor cross functional teams in regulated industry best practices for software development, quality system compliance practices, data quality and audit preparation• Develop, Implement and manage Health Catalyst Computer System Validation (Products & QMS tools) program• Develop and monitor Quality metrics for continuous improvement and reporting to leadership -
Quality Control And Supplier Quality ManagerAncestry Apr 2017 - Mar 2021Lehi, Ut, Us• Provide strategic guidance to organization on vendor selection and qualification, working with Legal, Purchasing and Operations.• Oversee the quality engineering efforts for all design and process development projects• Coach/Mentor cross-functional and Contract Manufacturing Organization teams in regulated industry best practices for product development, quality system compliance practices and audit preparation.• Contract Manufacturing Day-to-Day Quality Management for non-sterile IVD Device, including: o Performance analysis & Reporting via Quarterly Business Reviews o Qualification & Maintenance Audits for contract manufacturing (ISO 13485 & FDA 21 CFR part 820) partners and clinical laboratories (CAP/CLIA) o Nonconformance & Complaint Investigation & Resolution, SCAR, Process V&V, MDR/Vigilance Reporting, Scorecard for Global (US, Asia, EU) Supply Chain including manufacturing, laboratory, biobank, fulfillment & clearing house o Trend analysis, process capability, Gage R&R, Process V&V, test method development & validation, factory/site acceptance testing, test equipment calibration/validation, shipping validation, time studies, clinical lab operations, biorepository operations (sample storage/retrieval)• Lead a team to manage internal QMS processes across multiple sites, including: o Software/Computer System Validation, Design Control, Design/Tech Transfer, Document Control, CAPA, Nonconformance, Training• Perform internal audits of operations, engineering and QMS programs -
Quality Engineer IiIcu Medical Oct 2014 - Apr 2017San Clemente, Ca, Us• Class II Sterile Medical and Combination Device Design Control, including: Design V&V, Test Method Development & Validation, Risk Analysis/Assessment, Software V&V, DHF Document Preparation• Production & Process Control, including: Batch Record Review/Approval, Process Capability Studies, Gage R&R Studies, SPC, CAPA & Nonconformance RCA, Injection Molding/Automated Equipment Process V&V• Supplier Quality, including: Qualification, Audit, Nonconformance, SCAR, Process V&V, Quality Data Reporting, Scorecard, Performance Monitoring & Trending• Audit, including: Perform internal audits and assist with FDA/Notified Body audits as assigned• Perform Post Market Surveillance activities, updating DHF and Risk Documentation, or taking field action as necessary. -
Quality EngineerBlackrock Neurotech Mar 2012 - Oct 2014Salt Lake City, Utah, UsFor electrical (neurophysiology) hardware/software: - Continuous process improvement/process mapping - Design control (new product development/product improvement) - Metric development and data analysis - Design and process V&V - CAPA, Complaint, NLR - Project Management- Aided CFO with brokering deal to acquire rights to 3rd party technology - Promoted from quality specialist -
Quality Supervisor/Production SupervisorAdvanced H2O Dec 2010 - Apr 2012QMS Manager, Document Control Specialist, Quality Lab Supervisor, HACCP Manager, SQF Practitioner, Internal Auditor, Production SupervisorAs Quality Supervisor: Developed Quality Management System. Helped to improve and maintain FDA/SQF compliance and certification through employee quality and GMP training, process improvement efforts and internal auditsAs Production Supervisor: Helped to improve operational efficiency while managing ~30 direct reportsPromoted from Lab Coordinating Lead
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Lab Technologist I - VirologyArup Laboratories Dec 2008 - Nov 2010Salt Lake City, Utah, Us- Preparation of patient samples for execution of viral diagnostic testing for infectious disease group.- Reading and reporting of diagnostic test results.- Lab equipment repair and calibration.
Zach Sexton Skills
Quality Management
Change Control
Regulatory Affairs
Food Microbiology
Validation
Process Improvement
Quality Assurance
Quality System
Risk Management
Document Control
Quality Auditing
Microsoft Excel
Document Management
Cqe
Quality Control
Spc
Capa
Fda
Iso 13485
Zach Sexton Education Details
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Kennesaw State UniversityQuality Assurance -
Weber State UniversityChemistry
Frequently Asked Questions about Zach Sexton
What company does Zach Sexton work for?
Zach Sexton works for Onestudyteam
What is Zach Sexton's role at the current company?
Zach Sexton's current role is Director of Quality and GxP Compliance.
What is Zach Sexton's email address?
Zach Sexton's email address is za****@****yst.com
What schools did Zach Sexton attend?
Zach Sexton attended Kennesaw State University, Weber State University.
What are some of Zach Sexton's interests?
Zach Sexton has interest in Social Services.
What skills is Zach Sexton known for?
Zach Sexton has skills like Quality Management, Change Control, Regulatory Affairs, Food Microbiology, Validation, Process Improvement, Quality Assurance, Quality System, Risk Management, Document Control, Quality Auditing, Microsoft Excel.
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