Regulatory Requirements System Integrity Solutions Director- Life Science

RSM US LLP • Boston, MA

18d

About The Position

We are the leading provider of professional services to the middle market globally, our purpose is to instill confidence in a world of change, empowering our clients and people to realize their full potential. Our exceptional people are the key to our unrivaled, culture and talent experience and our ability to be compelling to our clients. You’ll find an environment that inspires and empowers you to thrive both personally and professionally. There’s no one like you and that’s why there’s nowhere like RSM. 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.

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 diverse backgrounds and technical expertise.
• Adept at recognizing the client's actual needs (beyond their stated requests) and developing compelling business cases for optimal solutions within resource limitations.
• Strong executive presence and excellent communication skills.
• Strong organizational change management skills
• Identify opportunities to automate regulatory and validation workflows, including leveraging GRC tools, automated testing tools, and AI‑enabled documentation accelerators.
• Introduce innovative approaches to lifecycle validation, system integrity, and compliance management, especially within modern cloud ERP landscapes.
• Continuously improve processes around requirements tracking, risk identification, and system assurance.
• Accountable, self-starter, with the ability to quickly resolve issues and move forward
• FDA validation readiness experience
• Undergraduate degree in any one of these areas: entrepreneurship, business administration, program management, business operations, MIS, Accounting, Auditing or other similar degrees
• Minimum of 12+ years of experience in highly regulated program risk management over large transformations, strong understanding of the software development life cycle
• Professional certification required, certification for chief of staff would be nice to have but not required.

Nice To Haves

• Background in IT auditing would be preferred, but not required.
• certification for chief of staff would be nice to have but not required.

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

Benefits

• At RSM, we offer a competitive benefits and compensation package for all our people.
• We offer flexibility in your schedule, empowering you to balance life’s demands, while also maintaining your ability to serve clients.
• Learn more about our total rewards at https://rsmus.com/careers/working-at-rsm/benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Director