Senior Specialist, QA IT
Core
Provides independent Quality Assurance oversight for GxP computerised systems and digital solutions across their lifecycle, ensuring compliance, security, and reliability for regulated activities.
Role type
Senior Specialist, QA IT (GxP Systems)
Builds
Compliant, secure, and reliable technology solutions for regulated activities
Domain
Life Sciences / Pharma / GxP Compliance
Required skills
GxP regulatory requirements, risk-based assurance, data integrity (ALCOA++), supplier oversight, audit readiness, agile delivery assurance, change management, incident investigation, stakeholder communication
Preferred skills
AI assurance, process improvement, capability building
Technologies
GxP systems, digital solutions, cloud services, automation, analytics
Responsibilities
Provide QA oversight and approval for GxP systems; Review and approve validation plans, risk assessments, and release decisions; Ensure data integrity controls meet ALCOA++ principles; Partner with system owners to build compliance into solutions; Support audits and regulatory inspections; Interpret evolving regulatory expectations and translate into practical guidance; Conduct investigation of significant system failures and compliance events; Provide coaching and training on computerised-system assurance.
Seniority
Senior, hands-on IC