Director, Life Sciences ERP Risk Transformation Advisory

RSM US LLP; Edison (NJ); Hybrid; USD 142,000 - 286,000; Full time

Job summary

RSM US LLP in Edison, NJ seeks a Life Sciences ERP Risk Transformation Advisory Director to lead growth in the life sciences sector, building client relationships and expanding market presence across ERP-enabled transformations.

You will guide executive conversations on FDA, GxP, CSA, and validation, connect regulatory requirements to business outcomes, and collaborate with cross-functional specialists to deliver compliant, high-impact solutions. Travel up to 25% may be required.

Qualifications

• FDA validation readiness experience is required.
• Minimum of 10+ years of experience in highly regulated program risk management over large transformations.
• Strong understanding of FDA, GxP, CSA, and validation requirements within life sciences organizations.
• Ability to communicate complex validation, compliance, and regulatory concepts to executives without deep hands-on technical expertise.

Responsibilities

• Lead crossfunctional team spanning governance & compliance, risk management, application security, data governance, and FDA validation & assurance.
• Develop and expand market-leading ERP transformation risk offerings focused on FDA CSA/CSV validation readiness, system integrity, compliance, and business process controls in life sciences.
• Ensure application designs incorporate regulatory requirements, compliance, traceability, and IT controls.
• Review and approve solution designs for GxP boundaries and regulated processes.
• Establish governance frameworks ensuring integrity, traceability, and compliance across the implementation lifecycle.
• Drive resolution of regulatory and compliance issues and escalate gaps as needed.
• Ensure quality of client deliverables produced by SMEs, including risk logs and testing packages.
• Lead and mentor a multidisciplinary delivery team and mature internal methodologies and best practices.
• Shape go-to-market strategy for regulatory compliance and ERP transformation services; identify client needs and growth opportunities.
• Identify and pursue new business opportunities; manage engagement contracting and profitability.
• Communicate program risk to stakeholders and mitigate with value-driven solutions.
• Develop optimized delivery structures, including on/near/offshore resources and automation in delivery.

Skills

Regulatory compliance

ERP transformation leadership

Executive communication

Client relationship management

Education

Bachelor degree required

Professional certification required

Job description

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 derisk 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 Life Sciences ERP Risk Transformation Advisory Director will serve as a strategic growth leader within RSM's Business Application Risk Solutions practice, focused on expanding market presence and driving revenue across the life sciences sector.

This individual will build and grow client relationships, identify and pursue new business opportunities, and serve as a trusted advisor guiding organizations through complex ERP-enabled transformations while addressing FDA, GxP, CSA, validation, compliance, and system integrity requirements.

The ideal candidate brings a strong understanding of regulatory requirements associated with ERP implementations and can confidently articulate validation, compliance, and risk management considerations during executive-level conversations. While deep technical expertise is not required, this individual must be able to connect regulatory requirements to business outcomes and collaborate effectively with technical specialists responsible for solution delivery.

Significant experience supporting large-scale ERP implementations, including SAP, Oracle, NetSuite, or Microsoft Dynamics environments, is critical.

Business Development & Growth Leadership

• Drive revenue growth by identifying, developing, and closing new business opportunities across the life sciences marketplace.
• Build and maintain executive-level relationships with prospects, clients, technology alliance partners, and industry stakeholders.
• Lead sales pursuits from opportunity identification through proposal development, negotiation, and close.
• Collaborate with RSM client service teams to identify cross-functional and cross-selling opportunities across ERP, risk, compliance, cybersecurity, and transformation services.
• Develop and execute market strategies that expand RSM's presence in FDA-regulated industries.
• Represent RSM at industry events, conferences, and client roundtables to enhance brand recognition and generate pipeline opportunities.
• Act as a trusted advisor to client executives by helping them understand business, operational, and regulatory risks associated with ERP transformation programs.
• Maintain and grow a healthy sales pipeline while achieving individual and practice revenue goals.

Responsibilities:

• Lead a crossfunctional team of subjectmatter experts spanning: Governance & compliance, Risk management, Application security, Data governance, IT controls FDA validation & assurance
• Develop and expand market-leading service offerings focused on ERP transformation risk, FDA CSA/CSV validation readiness, system integrity, compliance, and business process controls within life sciences organizations.
• 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. nonregulated process flows, and required IT controls.
• Establish and manage programwide 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.

• Help shape RSM's go-to-market strategy for regulatory compliance and ERP transformation services, identifying emerging client needs, industry trends, and growth opportunities.

• 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:

• Demonstrated success generating revenue and developing client relationships within consulting, advisory, ERP transformation, or regulatory compliance services.
• Extensive experience supporting or advising large ERP transformation programs involving SAP, Oracle, NetSuite, Microsoft Dynamics, or similar platforms.
• Strong understanding of FDA, GxP, GMP, CSA, and validation requirements within life sciences organizations.
• Ability to communicate complex validation, compliance, and regulatory concepts to executive and business stakeholders without requiring deep hands-on technical expertise.
• Proven ability to develop compelling business cases and articulate the value of risk, compliance, and validation investments during major transformation initiatives.
• Experience leading pursuit teams, responding to RFPs, developing proposals, and closing consulting engagements.
• Strong executive presence with exceptional presentation, relationship-building, and consultative selling skills.
• Experience leading diverse teams of delivery specialists, architects, compliance professionals, and consultants.
• Ability to identify client challenges and align solutions that drive measurable business outcomes while managing regulatory risk.
• 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
• Bachelor degree required
• Minimum of 10+ 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.Learn more about our total rewards at https://rsmus.com/careers/working-at-rsm/benefits.

We believe flexibility and in-person connection both play an important role in how we work and grow. Most roles at RSM follow a hybrid workstyle, which means team members are aligned to an RSM office and come together in person when it best supports clients, teams, development or relationship-building. Some roles may be virtual or primarily on-site based on role requirements, team priorities and client needs.

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 [e-mail].

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.

Compensation Range: $141,900 - $286,000

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