Assoc. Dir , Technology Compliance
Core
Lead site functional and cross-functional structures for computerized system validation (CSV) and IT/OT compliance in biologics drug substance manufacturing.
Role type
Associate Director of Compliance/CSV Lead
Builds
High-quality biologics products for Clinical Supply, Registration, and Commercial Launch
Domain
Biopharmaceuticals / Biologics Manufacturing / IT Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Computer System Validation (CSV), IT/OT Compliance, Regulatory Requirements (21CFR Part 11, EMEA Annex 11), Audit Management, Change Management, Risk Assessments, SDLC, Data Integrity, Project Management Leadership, GxP Standards (ISA S95/S88), Cloud/SaaS Validation, Manufacturing Business Processes
Preferred skills
Quality Management Systems (QMS), Business Process Re-engineering, Manufacturing Analytics, Real-time Shopfloor Integration, Application Development Methodologies
Technologies
Cloud platforms, SaaS, modern analytics, data integration architecture, real-time shopfloor systems, lab systems
Responsibilities
Lead regional cross-site alignment for CSV and IT/OT compliance; Execute risk assessments for new technologies; Represent compliance to internal/external auditors; Manage deviations, CAPAs, and incident investigations; Champion SDLC policy changes; Liaise with global compliance teams for consistency.
Seniority
Senior, hands-on IC with leadership responsibilities