Regulatory Requirements System Integrity Solutions Director- Life Science

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RSMs Business Application Risk Solutions practice specializes in managing governance, risk, security, data, and compliance across the full lifecycle of core business applications—from implementation through steady-state operations.  We help organizations de‑risk transformations through independent verification and validations (IV&Vs), or through regulatory requirements system integrity solutions including FDA/GxP/CSA validation and system integration readiness, program risk management, and rigorous data quality validation and analytics. We design and manage integrated and scalable compliant application security solutions. We unlock the power of business applications, enabling automation to manage operational and regulatory compliance risk, or implementing intelligent controls, compliance analytics, and business application GRC solutions.

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 (SAP, Oracle, NetSuite, Dynamics) 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.

Responsibilities:

• Lead a cross‑functional team of subject‑matter experts spanning: Governance & compliance, Risk management, Application security, Data governance, IT controls FDA validation & assurance
• Develop broad service offerings for clients including performing validation strategy assessments focusing on risk, cost, visibility and effectiveness, developing validation strategy master plans, validation SOPs, implementing enabling technology and executing validation testing
• Ensure application design decisions (configuration, integrations, data model, workflows) incorporate necessary regulatory requirements, compliance, traceability, and control requirements.
• Review and approve solution designs to ensure alignment with GxP boundaries, regulated vs. non‑regulated process flows, and required IT controls.
• Establish and manage program‑wide governance frameworks that ensure integrity, traceability, and compliance throughout the full implementation lifecycle.
• Drive resolution of regulatory and compliance issues, serving as the escalation point for solution design, validation, or control gaps.
• Ensure quality of all client deliverables created by the technical SMEs, including risk logs, assessment reports, mitigation plans, design documentation, and testing packages.
• Direct the creation of governance models, risk and control matrices, access control strategies, and data integrity safeguards across ERP platforms.
• Lead, mentor, and grow a multidisciplinary team of solution engineers, validation SMEs, GRC specialists, security architects, and data governance professionals.
• Build and mature internal methodologies, accelerators, templates, and best practices to enhance delivery consistency and efficiency.
• Drive capability development in FDA validation, ERP controls, and regulatory requirement frameworks within the broader practice.
• Identify and drive new business opportunities through demonstrating value.
• Accountable for engagement contracting, financials, including budgeting, forecasting, and financial reporting, to ensure profitability.
• Effectively communicate program risk to key stake holders along with mitigating solutions across the enterprise and aid in managing resistance through the ability to communicate value and awareness.
• Develop an optimized delivery structure that will include determining the mix of resources both on, near and offshore as well as working with the team to integrate automation into delivery. Maintain high quality documentation standards

Position Requirements:

• Proficient in FDA, GxP, and GMP IT validation, as well as other regulatory standards within the life sciences sector.
• Demonstrated success in interpreting and applying regulatory requirements—including FDA/GxP validation and system readiness—for deploying business systems like SAP, NetSuite, Oracle, and D365 in the Life Sciences industry.
• Experienced in leading teams with