Digital Quality Lead
Signant Health
Salary: $$$
Type:
Tiempo completo
Tags: Agile DevOps Cloud Computing Google Cloud Platform
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.
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Job functions
Complex Technical SDLC Reviews:
- Conduct detailed technical reviews of high-complexity Product SDLC documentation
- Evaluate validation deliverables for major SmartSignals® releases and product enhancements
- Review high-complexity study configuration documentation including multi-country stratification, complex randomization, and novel trial designs
- Assess validation evidence for completeness, adequacy, and regulatory defensibility
- Identify gaps or risks in validation approaches and recommend mitigation strategies
Technical Mentorship (Non-Supervisory):
- Mentor Digital Quality Specialists on technical validation methodologies
- Provide guidance on complex regulatory interpretation and application
- Share best practices and lessons learned from inspections and challenging scenarios
- Review work products and provide constructive technical feedback
- Facilitate knowledge transfer through documentation and training sessions
Risk Assessment & Validation Strategy:
- Develop risk assessment strategies for complex Product and Study validations
- Define critical controls and appropriate validation approaches based on risk
- Create validation strategies that balance regulatory rigor with business efficiency
- Apply Computer Software Assurance (CSA) and risk-based testing methodologies
- Ensure validation approaches align with GAMP 5, ICH E6(R3), and applicable regulations
- Bridge technical system understanding with regulatory requirements
GCP Compliance Assessment:
- Evaluate Product and Study systems for GCP compliance per ICH E6(R3)
- Assess 21 CFR Part 11 and EU Annex 11 compliance for electronic records/signatures
- Review audit trail functionality and data integrity controls
- Verify ALCOA++ principles application in system design and configuration
- Ensure sponsor and investigator access requirements are appropriately addressed
Qualifications and requirements
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
Conditions
Source: GetOnBoard | Main Category: Other