Digital Quality Lead en Signant Health

About Signant Health

At Signant Health, we help bring life-changing treatments to patients faster. We are a global evidence generation company supporting clinical trials through smart technology, scientific expertise, and hands-on operational support — because better data leads to better healthcare decisions. Our teams work at the intersection of science, technology, and patient experience, delivering digital solutions that make clinical trials more efficient, accurate, and accessible worldwide.

About the Role
The Digital Quality Lead serves as a Complex Technical Subject Matter Expert (SME) for Product and Study validation activities. This is a technical leadership role focused on hands-on execution of high-complexity SDLC reviews, inspection readiness, and mentorship of Digital Quality Specialists. The Lead operates as the frontline quality expert during inspections and audits, demonstrating technical mastery while building capability across the team.

Este empleo es publicado por getonbrd.com.

Education & Experience:

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field required
• Minimum 5 years of experience in pharmaceutical/biotechnology quality or validation and hands-on computerized systems validation experience
• Proven experience conducting SDLC reviews for software products in regulated environments
• Direct participation in at least 3 regulatory inspections or major customer audits
• Experience with clinical trial systems (eCOA, RTSM, eConsent, IRT, EDC)
• Track record of successfully mentoring junior quality professionals

Technical Knowledge:

• Expert-level knowledge of ISPE GAMP 5 principles and practical application
• Strong understanding of FDA CSA guidance and risk-based validation
• Comprehensive knowledge of ICH E6(R3) GCP requirements for computerized systems
• Deep familiarity with 21 CFR Part 11, EU Annex 11, and data integrity requirements
• Understanding of software development methodologies (Agile, Waterfall, DevOps)
• Knowledge of testing approaches including scripted, unscripted, and exploratory testing

Competencies & Skills:

Technical Expertise:

• Mastery of validation methodologies and regulatory requirements
• Software testing strategy and critical control identification
• Risk assessment and Quality Risk Management application
• GCP compliance evaluation for clinical systems
• Documentation review and technical writing excellence

Problem-Solving:

• Critical thinking and diagnostic approach to quality challenges
• Root cause analysis and preventive strategy development
• Balancing regulatory compliance with practical implementation
• Creative solutions to novel validation scenarios
• Ability to work through ambiguity and emerging requirements

Collaboration:

• Building relationships across Quality, Technology, and Operations
• Influencing without direct authority
• Working effectively in matrixed environments
• Coordinating across time zones and geographies
• Contributing to team success and shared goals