Life Sciences Regulatory & System Integrity Director

RSM US LLP

Boston (MA)

On-site

USD 142,000 - 286,000

Full time

14 days+

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Job summary

RSM US LLP in Boston seeks a Regulatory Requirements System Integrity Solutions Director to advise clients through complex FDA/GxP validation and ERP deployments (SAP, Oracle, NetSuite, Dynamics) in the life sciences sector. You will lead a cross‑functional team of governance, risk, application security, data governance, and IT controls professionals.

You will develop validation strategies, set master plans, review designs for regulatory alignment, and manage program governance while driving

Qualifications

Experience leading risk and regulatory programs in life sciences.
Strong ability to interpret FDA validation requirements and translate into project delivery.
Proven track record of managing cross-functional teams across governance, risk, and IT controls.

Responsibilities

Lead cross-functional team spanning governance, risk, application security, data governance and IT controls.
Develop validation strategy master plans, SOPs, and testing approaches.
Review designs to ensure regulatory alignment and traceability within GxP boundaries.
Establish program-wide governance frameworks ensuring integrity and compliance.
Drive capability development in FDA validation and ERP controls.