Kevin Bryant Email and Phone Number

• Accountable, inclusive, and motivated leader with 13 years of Computer System Validation, Data Integrity, Quality, Team/Project Lead, and Consulting experience in GxP (particularly, GMP) environments within the Pharmaceutical and Biomedical Device industries, with a focus on 21 CFR Part 11 compliance.• Active and effective communicator with proven ability to successfully manage diverse teams/personalities, establish and build stakeholder/client rapport, maintain strategic business partnerships, and coordinate both inter- and intradepartmental activities associated with FDA commitments, gap assessment remediation, instrument and equipment validation, batch release, special test requests, and stability time-points.• Versatile skillset and ability to support site start-up activities, manage multiple projects, identify and resolve issues, oversee/perform routine lab functions, execute root cause investigations, implement Change Controls and Corrective & Preventive Actions (CAPAs), and train personnel, both independently and as part of a team.• Technical writing experience includes writing and revising Data Integrity Remediation Plans, Data Integrity Assessments / Summary Reports, Validation Plans, User Requirements Specifications, Regulatory Requirements Assessments, Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Validation Summary Reports, Standard Operating Procedures, Work Instructions, Change Controls, Deviations/Discrepancies, CAPAs, Non-Conformance Reports, and Quarterly Trending Reports.