Associate Director of QA Computer Systems
Core
Lead validation planning, execution, and documentation for computerized systems (EDMS, QMS, ERP, RIM) in a regulated pharmaceutical environment to ensure GxP compliance.
Role type
Senior IC Associate Director of QA Computer Systems
Builds
Validated computerized systems supporting clinical development and commercial operations
Domain
Life Sciences / Pharmaceutical / Computer Systems Validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer system validation, GxP regulatory knowledge, FDA 21 CFR Part 11, GAMP 5, EU/EMA GMP Annex 11, Veeva Vault, SDLC methodologies, risk assessment, change control, vendor qualification, data integrity
Preferred skills
Multiple GxP system implementations, employee/contractor management, Veeva Vault Administrator certification, electronic validation management
Technologies
Veeva Vault, SharePoint, Microsoft Word, Excel, PowerPoint, Adobe Acrobat
Responsibilities
Lead validation planning, execution, and documentation for new and existing computerized systems; Create, execute, and approve validation deliverables such as plans, risk assessments, test scripts, and reports; Maintain the validated state of QA computer systems through ongoing documentation and lifecycle management; Identify opportunities to streamline and scale validation processes; Ensure data integrity principles are incorporated into system processes; Support vendor qualification, audits, and inspections; Lead ongoing system lifecycle activities including change controls and periodic reviews; Manage vendor contracts and software licensing; Partner with IT to improve system functionality while maintaining compliance; Support inspection readiness by maintaining accurate documentation.
Seniority
Senior, hands-on IC with leadership responsibilities