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Zach Galloway
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Tennessee, United States
Résumé
Jobs
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Manager, Regulatory and Quality AssuranceCogstateOct 2023 - Current (2 years 8 months)• Directed 60+ regulatory, sponsor, and CRO audits, including clinical site audits across FDA, EU MDR, MHRA, TGA, PMDA, and Health Canada, securing zero critical findings and boosting compliance scores. • Implemented QMS process improvements, reducing regulatory audit findings by 60% within one year through targeted CAPA and risk management enhancements (ISO 14971). • Oversaw computer system validation (CSV) and led clinical trial risk assessments, ensuring compliance with 21 CFR Part 11 , EU MDR Annex 11 , ISO 14155, and ICH E6 GCP (R2 & R3) standards for clinical investigations. • Managed post-market surveillance, vigilance reporting, customer complaints, executing site audits, and vendor management to mitigate regulatory risks and co- BQuality Assurance DirectorBehavrJan 2022 - Oct 2023 (1 year 10 months)• Led regulatory and Quality Affairs during $13M DTx SaMD merger, enforcing FDA GLP/GCP/GMP compliance and clinical trial protocol adherence, culminating in successful integrations with zero compliance gaps. • Established SaMD software validation frameworks per IEC 62304, driving FDA pre-submissions, 510(k) clearances, and De Novo approvals for medical device submissions. • Executed GCP and ICH E6 (R2) audits, including clinical site audits, pinpointing compliance vulnerabilities and spearheading risk analysis for 14+ team-led clinical trials, enhancing trial integrity. • Directed 14-member regulatory/clinical quality team, instilling continuous improvement culture that reduced deviation resolution times by 30% through targeted training
- PAssistant Quality ManagerPermobilJan 2021 - Jan 2022 (1 year 1 month)• Deployed Power BI visual management system, improving real-time regulatory KPI monitoring by 40% and KPI tracking by 40% and aligning with eQMS standards for FDA 21 CFR Part 11 & EU MDR Annex 11 compliance. • Developed company-wide job architecture for quality/regulatory teams, adopted across departments to standardize clinical and risk management processes. • Guided cross-departmental RCA and CAPA deployments, cutting compliance incidents by 50% through ISO 13485- aligned audits and site inspections. • Administered NCR, CAPA systems using Power BI and SQL, streamlining data for regulatory submissions and audit reporting per MDSAP requirements.
- AQuality EngineerAphena Pharma SolutionsMay 2020 - Jan 2021 (9 months)• Led cGMP deviation investigations and CAPA implementations, resolving 75+ issues and maintaining 100% compliance in pharmaceutical and OTC processes. • Delivered cGMP training modules, increasing team compliance knowledge by 40% and reducing audit findings in clinical validation areas. • Reviewed and approved change controls, IQ/OQ/PQ protocols, and validation docs, ensuring flawless regulatory documentation for FDA & Board of Pharmacy inspections.
- USupplier Quality EngineerU.S. Tsubaki Automotive, LLCFeb 2019 - May 2020 (1 year 4 months)• Drove supplier development and scoring system enhancements, achieving 25% better quality performance through APQP audits to IATF 16949 compliance. • Organized APQP docs for launches, facilitating seamless regulatory compliance and audit readiness per AIAG and VDA standards. • Conducted monthly/quarterly supplier site audits, tracking compliance and elevating scores to minimize risks in supply chain.
- Supplier Quality EngineerAdientMar 2017 - Feb 2019 (2 years)• Led four Lean Six Sigma projects, generating $347,000 in cost savings through 8D, PFMEA, and poka-yoke, applied to OEM compliance and risk management. • Boosted profitability with supplier chargeback system, doubling profits from quality discrepancies in 150+ commodities. • Oversaw Nissan/OEM compliance for suppliers, using 8D, 5-Whys, PFMEA to align with IATF 16949/ISO 9001 .
- CSupplier Quality EngineerChattanooga Seating SystemsMay 2012 - Mar 2017 (4 years 11 months)• Implemented FMEA to slash supplier defects by 50%, enhancing performance via risk analysis tools. • Ensured IATF 16949/ISO 9001 compliance through regular site audits and training, optimizing processes with 8D and RCA. • Deployed Lean strategies, including Kanban and poka-yoke, reducing process waste by 35% in quality assurance.
Education
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- Master of ScienceUniversity of AlabamaMay 2020 - May 2022 (2 years 1 month)
- Bachelor of ScienceUniversity of Tennessee at ChattanoogaMay 2013 - May 2015 (2 years 1 month)
- Associate of ScienceNashville State Community CollegeMay 2010 - May 2012 (2 years 1 month)