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 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
• Background in IT auditing would be preferred, but not required.
• Travel could be up to 25%, based on client needs

Minimum Qualifications:

• FDA validation readiness experience
• Education: 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.

Standards of Performance:

• A self-starter with a process improvement mentality who is hands on, results-oriented, and leads by example
• A strong entrepreneurial spirit with the highest levels of professional and personal honestly, integrity and ethics
• Excellent organizational skills and the ability to prioritize multiple tasks, projects and assignments
• Ability to interact with all levels of client staff, including executives and senior managers
• Possess strong business ethics and willingness to adhere to stringent professional standards
• Ability to put forth additional effort to meet deadlines when necessary

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.

All applicants will receive consideration for employment as RSM does not tolerate discrimination and/or harassment based on race; color; creed; sincerely held religious beliefs, practices or observances; sex (including pregnancy or disabilities related to nursing); gender; sexual orientation; HIV Status; national origin; ancestry; familial or marital status; age; physical or mental disability; citizenship; political affiliation; medical condition (including family and medical leave); domestic violence victim status; past, current or prospective service in the US uniformed service; US Military/Veteran status; pre-disposing genetic characteristics or any other characteristic protected under applicable federal, state or local law.

Accommodation for applicants with disabilities is available upon request in connection with the recruitment process and/or employment/partnership. RSM is committed to providing equal opportunity and reasonable accommodation for people with disabilities. If you require a reasonable accommodation to complete an application, interview, or otherwise participate in the recruiting process, please call us at 800-274-3978 or send us an email at [email protected].

RSM does not intend to hire entry level candidates who will require sponsorship now OR in the future (i.e. F-1 visa holders). If you are a recent U.S. college / university graduate possessing 1-2 years of progressive and relevant work experience in a same or similar role to the one for which you are applying, excluding internships, you may be eligible for hire as an experienced associate.

RSM will consider for employment qualified applicants with arrest or conviction records. For those living in California or applying to a position in California, please click here for additional information.

At RSM, an employee’s pay at any point in their career is intended to reflect their experiences, performance, and skills for their current role. The salary range (or starting rate for interns and associates) for this role represents numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, location, etc. As such, pay for the successful candidate(s) could fall anywhere within the stated range.

Individuals selected for this role will be eligible for a discretionary bonus based on firm and individual performance.