Assoc Director, BI&T Compliance & CSV
Core
Lead the Campus IT Compliance and Computer System Validation (CSV) team to ensure GxP business operations, regulatory compliance, and audit readiness for a pharmaceutical manufacturing site.
Role type
Senior IC Associate Director, IT Compliance & CSV
Builds
Regulated IT systems and validation processes for GMP operations
Domain
Pharmaceutical manufacturing / Quality Assurance / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), GxP regulations, 21 CFR Part 11, GAMP standards, IT compliance, team leadership, project management, SLA management, regulatory agency liaison, technical writing, process improvement
Preferred skills
ISO 9001, Quality principles, system development lifecycles, cross-functional collaboration, vendor management, innovation in IT solutions
Technologies
ServiceNow, regulated IT systems, project dashboards
Responsibilities
Lead and manage the Devens Campus IT Compliance and CSV team; Act as the CSV process owner onsite; Ensure GxP compliance and audit readiness for IT systems; Manage service providers and SLAs; Represent the site during regulatory inspections; Drive continuous improvement of team productivity and KPIs
Seniority
Senior, hands-on IC