Regulatory Requirements System Integrity Solutions Director- Life Science

RSM UK

Boston, United States
Base: $141,900 - $286,000; bonus/equity: discretio...
On-site
Fda/gxp/csa validation expertise
Sap, oracle, netsuite, dynamics implementation experience
Life science industry regulatory requirements
Lead a cross-functional team of subject-matter experts in governance, risk, application security, data governance, IT controls, and FDA validation & assurance

Job Summary

  • Lead a cross-functional team of subject-matter experts in governance, risk, application security, data governance, IT controls, and FDA validation & assurance.
  • Develop service offerings including validation strategy assessments, master plans, SOPs, and execution of validation testing for clients navigating business application implementations.
  • RSM offers a competitive benefits and compensation package, flexibility in schedule, and empowers employees to balance life's demands while serving clients.

Matching Summary

Lead a cross-functional team of subject-matter experts in governance, risk, application security, data governance, IT controls, and FDA validation & assurance.

Salary

Base: $141,900 - $286,000; Bonus/Equity: Discretionary bonus based on firm and individual performance; Benefits: Competitive benefits and compensation package

Skills & Requirements

Must-have

  • FDA/GxP/CSA validation expertise
  • SAP, Oracle, NetSuite, Dynamics implementation experience
  • Life science industry regulatory requirements
  • Cross-functional team leadership
  • Governance, risk, security, data, compliance management

Nice-to-have

  • Process improvement mentality
  • Entrepreneurial spirit
  • Executive presence and communication skills
  • Organizational change management skills
  • Automation of workflows

Key Requirements

  • 12+ years of experience in regulated program risk management
  • Proficient in FDA, GxP, and GMP IT validation
  • Undergraduate degree in relevant field
  • Professional certification required

Work Rights

Not specified

Tailored Resume

Cover Letter