Regulatory Requirements System Integrity Solutions Director- Life Science

Regulatory Requirements System Integrity Solutions DirectorRSMs 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 & assuranceDevelop 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 testingEnsure 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 stakeholders 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 standardsPosition 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 skillsIdentify 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 forwardBackground in IT auditing would be preferred, but not required.Travel could be up to 25%, based on client needsMinimum Qualifications:FDA validation readiness experienceEducation: Undergraduate degree in any one of these areas: entrepreneurship, business administration, program management, business operations, MIS, Accounting, Auditing or other similar degreesMinimum of 12+ years of experience in highly regulated program risk management over large transformations, strong understanding of the software development life cycleProfessional certification required, certification for chief of staff would be nice to have but not required.Standards of Performance:A self-starter with a process improvement mentality who is hands on, results-oriented, and leads by exampleA strong entrepreneurial spirit with the highest levels of professional and personal honesty, integrity and ethicsExcellent organizational skills and the ability to prioritize multiple tasks, projects and assignmentsAbility to interact with all levels of client staff, including executives and senior managersPossess strong business ethics and willingness to adhere to stringent professional standardsAbility to put forth additional effort to meet deadlines when necessary