Regulatory Requirements System Integrity Solutions Director- Life Science
Core
Strategic advisor leading regulatory compliance and system integrity solutions for business application implementations in the life sciences industry.
Role type
Director, Regulatory Requirements System Integrity Solutions
Builds
Compliant application security solutions, validation strategies, and governance frameworks for ERP platforms (SAP, Oracle, NetSuite, Dynamics) in life sciences.
Domain
Life Sciences / Regulatory Compliance / IT Governance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FDA validation readiness, GxP/GMP IT validation, program risk management, ERP system implementation, team leadership, business case development, automation of regulatory workflows, lifecycle validation, system integrity management, requirements tracking, risk identification.
Preferred skills
IT auditing background, cloud ERP landscape expertise, GRC tools, automated testing tools, AI-enabled documentation accelerators.
Technologies
SAP, Oracle, NetSuite, Dynamics 365, GRC tools, automated testing tools, AI-enabled documentation accelerators
Responsibilities
Lead cross-functional teams of governance, risk, and security experts; develop validation strategy master plans and SOPs; review solution designs for GxP alignment; establish program-wide governance frameworks; drive resolution of regulatory compliance issues; ensure quality of client deliverables; mentor multidisciplinary teams; build internal methodologies and best practices; identify new business opportunities; manage engagement contracting and financials.
Seniority
Director, strategic advisor and team leader