I V & V Lead

Position: I V & V Lead Location: Bay-Area (Remote) Detailed Job Role: Consulting/Advisory expertise in building Verification and Validation strategies for large healthcare organizations Knowledge on Healthcare industry regulations including FDA, and EMEA, etc. Hands-on implementing/advising industry compliances in line with ISO, 21 CFR Part 11, HIPAA, etc. Prior experience in strategizing computer system validation (CSV) and Computer System Assurance (CSA) Must-have experience in designing procedures for system qualification protocols including IQ, OQ, and PQ (SOPs, software testing/validation techniques, Change Management, Reporting, Documentation, etc.) Supervise and advise team in end-to-end activities (right from product requirements through V&V testing) Hands-on verification and validation of digital health applications, especially test automation Continuous review and improvement of Standard Operating Procedures Define and implement technical solutions that support in enhancing product quality and automation Understand application in scope including its integrations, workflows and customizations Review and analyze the compliance requirements and existing processes Perform gap analysis on the existing processes and provide recommendations for improvement Define processes required to meet the industry standards for computerized systems – CSV, 21 CFR Part 11, HIPAA Perform pilot validation on one scenario, and demonstrate the result Implement standard processes across the software lifecycle, as applicable§Train Evidation team on the new processes defined"