Life Sciences ERP Risk Transformation Advisory Manager

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.

RSM’s 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 validation (IV&V), regulatory 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, scalable, and compliant application security solutions. We also help organizations unlock the power of business applications through automation, intelligent controls, compliance analytics, and business application GRC solutions.

The Life Sciences ERP Risk Transformation Advisory Manager will play a key role within RSM’s Business Application Risk Solutions practice, supporting client delivery, relationship development, and growth initiatives across the life sciences sector.

This individual will manage client relationships and engagements, support the identification and pursuit of new business opportunities, and serve as a trusted advisor to organizations undergoing complex ERP-enabled transformations while addressing FDA, GxP, CSA, validation, compliance, and system integrity requirements.

The ideal candidate will bring a strong understanding of regulatory requirements associated with ERP implementations and be able to confidently articulate validation, compliance, and risk management considerations to client stakeholders. While deep hands-on technical expertise is not required, this individual should be able to connect regulatory requirements to business outcomes and collaborate effectively with technical specialists responsible for solution delivery.

Experience supporting large-scale ERP implementations, including SAP, Oracle, NetSuite, Microsoft Dynamics, or similar platforms, is highly valued.

Business Development & Growth

• •Support revenue growth by identifying and developing new business opportunities across the life sciences marketplace.
• •Build and maintain strong relationships with clients, prospects, technology alliance partners, and industry stakeholders.
• •Participate in sales pursuits, including opportunity development, proposal creation, presentations, and client discussions.
• •Collaborate with RSM client service teams to identify cross-functional and cross-selling opportunities across ERP, risk, compliance, cybersecurity, and transformation services.
• •Contribute to market initiatives that expand RSM’s presence within FDA-regulated industries.
• •Participate in industry events, conferences, client roundtables, and other market-facing activities.
• •Serve as a trusted advisor to client stakeholders by helping them understand business, operational, and regulatory risks associated with ERP transformation programs.
• •Support pipeline development and practice growth objectives in collaboration with senior practice leaders.

Responsibilities

• •Manage cross-functional engagement teams that may include specialists across governance and compliance, risk management, application security, data governance, IT controls, and FDA validation and assurance.
• •Manage and contribute to client engagements focused on ERP transformation risk, FDA CSA/CSV validation readiness, system integrity, compliance, and business process controls within life sciences organizations.
• •Support the development and enhancement of service offerings focused on ERP transformation risk, regulatory compliance, validation, and system integrity.
• •Assess application design decisions, including configuration, integrations, data models, and workflows, for alignment with regulatory, compliance, traceability, and control requirements.
• •Review solution designs and provide recommendations related to GxP boundaries, regulated and non-regulated process flows, validation requirements, and IT controls.
• •Manage engagement-level governance frameworks designed to support integrity, traceability, risk management, and compliance throughout the implementation lifecycle.
• •Identify regulatory, compliance, validation, and control issues and collaborate with client stakeholders and RSM specialists to develop practical solutions.
• •Manage the quality and timely completion of client deliverables, including risk assessments, risk logs, mitigation plans, design documentation, control documentation, and testing packages.
• •Support the development of governance models, risk and control matrices, access control strategies, and data integrity safeguards across ERP platforms.
• •Manage, coach, and develop consultants and other engagement team members.
• •Contribute to internal methodologies, accelerators, templates, and leading practices that improve delivery quality and consistency.
• •Contribute insights on emerging client needs, regulatory developments, industry trends, and growth opportunities to support RSM’s go-to-market strategy.
• •Identify potential business development opportunities through existing client relationships and successful engagement delivery.
• •Manage engagement financials, including budgeting, forecasting, resource planning, and financial reporting, in collaboration with engagement and practice leadership.
• •Effectively communicate program risks, recommendations, and mitigation strategies to client stakeholders, including senior management.
• •Support effective engagement delivery models, including coordination of onshore, nearshore, and offshore resources, as appropriate, and the incorporation of automation into delivery activities.
• •Maintain high-quality documentation standards across engagements.

Position Requirements

• •5-9 years of experience in consulting, advisory, ERP transformation, program risk management, regulatory compliance, or a related field, preferably within highly regulated industries.
• •Experience supporting large ERP transformation programs involving SAP, Oracle, NetSuite, Microsoft Dynamics, or similar platforms.
• •Strong understanding of FDA, GxP, GMP, CSA, CSV, validation, and related regulatory requirements within life sciences organizations.
• •Experience supporting FDA validation readiness activities in connection with technology or ERP implementations.
• •Ability to communicate validation, compliance, risk, and regulatory concepts clearly to both business and technical stakeholders.
• •Experience managing client engagements, workstreams, project teams, or complex transformation initiatives.
• •Ability to develop business cases and articulate the value of risk, compliance, controls, and validation investments during transformation initiatives.
• •Experience supporting business development activities, including RFP responses, proposal development, client presentations, and pursuit activities.
• •Strong presentation, communication, relationship-building, and consultative skills.
• •Experience working with diverse teams of technology, compliance, risk, security, and business professionals.
• •Ability to identify client challenges and develop solutions that support business objectives while appropriately managing regulatory risk.
• •IT audit experience preferred but not required.
• •Travel may be up to 25%, based on client needs.

Minimum Qualifications

• •Bachelor’s degree required.
• •5+ years of relevant professional experience in ERP transformation, program risk management, technology risk, regulatory compliance, lif