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"