Director, QA Validation & Computer Systems Assurance
Core
Lead QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance for a highly automated biopharmaceutical manufacturing site, ensuring compliance with FDA/EMA regulations and maintaining validated states for commercial and clinical production.
Role type
Director, QA Validation & Computer Systems Assurance
Builds
Validated state for process equipment, utilities, MES, LIMS, DCS, and enterprise platforms in GMP manufacturing
Domain
Biopharmaceutical manufacturing / Computer Systems Assurance (CSV)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk-based validation strategy, FDA CSA guidance (2022) & GAMP 5 expertise, SDLC framework governance, GxP software qualification, Data integrity by design, Regulatory inspection defense, Team leadership, Budget management
Preferred skills
Experience with continuous manufacturing and PAT instruments, Digital twin integration, Global quality alignment
Technologies
MES (Syncade, PAS-X), DCS/SCADA, LIMS, EBR, ERP, Data historians
Responsibilities
Own and maintain the Validation Master Plan (VMP), Design risk-based qualification programs, Ensure validation lifecycle documentation compliance, Lead periodic review programs, Oversee supplier/vendor assessments for GxP software, Ensure data integrity across automated systems, Partner with IT/Engineering on system integration, Review and approve GxP documents, Present validation programs during regulatory inspections, Lead and develop a team of validation scientists and engineers
Seniority
Director, strategic leadership & team management
