Life Sciences ERP Risk Transformation Lead

RSM US LLP; Boston (MA); Hybrid; USD 107,000 - 215,000; Full time

Job summary

RSM US LLP seeks a Life Sciences ERP Risk Transformation Advisory Manager to lead client engagements across ERP transformation, regulatory compliance, and risk management within FDA-regulated environments. You will manage cross-functional teams, drive FDA/CSA/CSV validation readiness, and enhance offerings in ERP risk and compliance while supporting growth of the life sciences practice.

The role emphasizes delivering measurable outcomes, collaborating with stakeholders, and contributing to RSM’s

Qualifications

• Bachelor’s degree required; 5+ years of relevant experience in ERP transformation, program risk management, technology risk, regulatory compliance, life sciences consulting, or a related area.
• Experience supporting large ERP transformation programs involving SAP, Oracle, NetSuite, Microsoft Dynamics, or similar platforms.
• Strong understanding of FDA, GxP, CSA, CSV, validation, and related regulatory requirements within life sciences organizations.
• Travel may be up to 25%, based on client needs.

Responsibilities

• Manage cross-functional engagement teams across governance, risk, security, data governance, IT controls, and FDA validation and assurance.
• Lead client engagements focused on ERP transformation risk, FDA CSA/CSV validation readiness, system integrity, and regulatory compliance.
• Develop and enhance service offerings for ERP transformation risk, regulatory compliance, validation, and IT controls.
• Identify and address regulatory, compliance, validation, and control issues with client stakeholders and RSM specialists.
• Oversee governance frameworks, risk and control matrices, access control strategies, and data integrity safeguards across ERP platforms.

Skills

Regulatory compliance

ERP risk management

FDA GxP knowledge

Client relationships

Regulatory communication

Education

Bachelor’s degree

Job description

RSM US LLP seeks a Life Sciences ERP Risk Transformation Advisory Manager to lead client engagements across ERP transformation, regulatory compliance, and risk management within FDA-regulated environments. You will manage cross-functional teams, drive FDA/CSA/CSV validation readiness, and enhance offerings in ERP risk and compliance while supporting growth of the life sciences practice.

The role emphasizes delivering measurable outcomes, collaborating with stakeholders, and contributing to RSM’s