Regulatory Requirements System Integrity Solutions Director- Life Science

RSM

Boston, United States
Base: $141,900 - $286,000; bonus/equity: discretio...
On-site
Fda/gxp/csa validation
Sap, oracle, netsuite, dynamics implementation
Governance, risk, security, data, compliance
The Regulatory Requirements System Integrity Solutions Director will be responsible for serving as a strategic advisor helping clients navigate risk and regulatory requirement needs during a business application implementation in the life-science industry

Job Summary

  • The Regulatory Requirements System Integrity Solutions Director will be responsible for serving as a strategic advisor helping clients navigate risk and regulatory requirement needs during a business application implementation in the life-science industry.
  • You would be overseeing a team of solution delivery technical experts of governance, risk, application security, data, controls, with regulatory requirement knowledge, including FDA validation.
  • RSMs Business Application Risk Solutions practice specializes in managing governance, risk, security, data, and compliance across the full lifecycle of core business applications.

Matching Summary

The Regulatory Requirements System Integrity Solutions Director will be responsible for serving as a strategic advisor helping clients navigate risk and regulatory requirement needs during a business application implementation in the life-science industry.

Salary

Base: $141,900 - $286,000; Bonus/Equity: discretionary bonus based on firm and individual performance; Benefits: Not specified

Skills & Requirements

Must-have

  • FDA/GxP/CSA validation
  • SAP, Oracle, NetSuite, Dynamics implementation
  • governance, risk, security, data, compliance
  • cross-functional team leadership
  • client strategic advisory
  • validation strategy development

Nice-to-have

  • process improvement mentality
  • entrepreneurial spirit
  • organizational change management skills
  • automation of regulatory workflows

Key Requirements

  • 12+ years of experience in program risk management
  • FDA validation readiness experience
  • Undergraduate degree
  • Professional certification

Work Rights

Not specified

Tailored Resume

Cover Letter