Life Sciences Regulatory & System Integrity Director

RSM US LLP; Boston (MA); On-site; USD 141,900 - 286,000; Full time

Benefits offered by this job

Flexible schedule

Job summary

RSM US LLP seeks a Regulatory Requirements System Integrity Solutions Director to guide clients through FDA validation and ERP program risk in life sciences. You will lead a multidisciplinary team of governance, risk, security, and data professionals, shaping strategy, controls, and compliance across SAP, NetSuite, Oracle, and D365 implementations.

You will build governance models, risk matrices, and validation accelerators while identifying new business opportunities and driving profitable

Qualifications

• Undergraduate degree required; field(s) listed include entrepreneurship, business administration, program management, MIS, accounting or auditing.
• Professional certification is beneficial, not mandatory.

Responsibilities

• Lead cross-functional teams spanning governance, risk, application security, data governance, and IT controls.
• Develop validation strategies, master plans, SOPs, enabling technologies, and testing plans.
• Ensure designs meet regulatory, traceability, and IT control requirements across ERP projects.
• Review designs for GxP boundaries and compliant processes; manage program-wide governance.

Skills

Governance

Risk management

Regulatory compliance

Application security

Data governance

IT controls

FDA validation

Leadership

Mentoring

Education

Bachelor's degree in Business/Operations/MIS/Accounting/Auditing

Tools

GRC tools

Automated testing tools

ERP platforms (SAP, NetSuite, Oracle, D365)

Job description

RSM US LLP seeks a Regulatory Requirements System Integrity Solutions Director to guide clients through FDA validation and ERP program risk in life sciences. You will lead a multidisciplinary team of governance, risk, security, and data professionals, shaping strategy, controls, and compliance across SAP, NetSuite, Oracle, and D365 implementations.

You will build governance models, risk matrices, and validation accelerators while identifying new business opportunities and driving profitable