Life Sciences ERP Risk Transformation Advisory Manager

RSM•Boston, MA

9d•Hybrid

About The Position

The Life Sciences ERP Risk Transformation Advisory Manager is part of RSM’s Business Application Risk Solutions practice, which supports governance, risk, security, data, and compliance across the lifecycle of core business applications. The role supports client delivery, relationship development, and growth initiatives across the life sciences sector, advising organizations undergoing complex ERP-enabled transformations and addressing FDA, GxP, CSA, validation, compliance, and system-integrity requirements. The manager oversees client relationships and engagements, supports new business pursuits, and helps clients connect regulatory requirements to business outcomes. The role works with technical specialists and cross-functional teams on ERP transformation risk, validation readiness, system integrity, compliance, and business process controls. Experience with large-scale ERP platforms such as SAP, Oracle, NetSuite, or Microsoft Dynamics is valued; deep hands-on technical expertise is not required. The position also contributes to practice growth and service development, manages engagement teams and financials, coaches team members, and communicates program risks and recommendations to client stakeholders. Travel may be up to 25%, based on client needs. Most roles at RSM follow a hybrid workstyle, with team members aligned to an RSM office and meeting in person when appropriate for clients, teams, development, or relationship-building. Compensation range: $107,000–$214,500, with eligibility for a discretionary bonus based on firm and individual performance.

Requirements

Bachelor’s degree required.
At least 5 years of relevant professional experience in ERP transformation, program risk management, technology risk, regulatory compliance, life sciences consulting, or a related area; the position requirements state 5–9 years of experience.
Experience supporting large-scale 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.
Experience supporting large-scale transformation programs and strong understanding of the software development lifecycle.
Experience managing client engagements, projects, workstreams, project teams, engagement teams, or complex transformation initiatives.
Ability to clearly communicate validation, compliance, risk, and regulatory concepts to business and technical stakeholders.
Ability to develop business cases and explain 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.
Self-starter with a process-improvement mindset; hands-on, results-oriented, and able to lead by example.
Entrepreneurial mindset and high standards of professional integrity and ethics.
Strong organizational skills and ability to prioritize multiple projects, responsibilities, and deadlines.
Ability to interact effectively with client stakeholders at all levels, including executives and senior managers.
Ability to adapt to changing client priorities and meet critical deadlines when necessary.
Willingness to adhere to professional standards and strong business ethics.

Nice To Haves

IT audit experience.
Relevant professional certification based on area of specialization.
Experience with ERP platforms such as SAP, Oracle, NetSuite, or Microsoft Dynamics is highly valued.

Responsibilities

Identify and develop new business opportunities across the life sciences marketplace; support pipeline development and practice growth.
Build and maintain 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 client service teams to identify cross-functional and cross-selling opportunities across ERP, risk, compliance, cybersecurity, and transformation services.
Contribute to market initiatives and participate in industry events, conferences, client roundtables, and other market-facing activities.
Advise client stakeholders on business, operational, and regulatory risks associated with ERP transformation programs.
Manage cross-functional engagement teams spanning governance and compliance, risk management, application security, data governance, IT controls, and FDA validation and assurance.
Manage and contribute to engagements focused on ERP transformation risk, FDA CSA/CSV validation readiness, system integrity, compliance, and business process controls.
Support development and enhancement of services related to ERP transformation risk, regulatory compliance, validation, and system integrity.
Assess application design decisions, including configuration, integrations, data models, and workflows, for regulatory, compliance, traceability, and control alignment.
Review solution designs and recommend approaches for GxP boundaries, regulated and non-regulated process flows, validation requirements, and IT controls.
Manage engagement-level governance frameworks that support integrity, traceability, risk management, and compliance throughout the implementation lifecycle.
Identify regulatory, compliance, validation, and control issues and work 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 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.
Provide insights on emerging client needs, regulatory developments, industry trends, and growth opportunities to support go-to-market strategy.
Identify potential business development opportunities through client relationships and successful engagement delivery.
Manage engagement financials, including budgeting, forecasting, resource planning, and financial reporting, in collaboration with engagement and practice leadership.
Communicate program risks, recommendations, and mitigation strategies effectively to client stakeholders, including senior management.
Support engagement delivery models that coordinate onshore, nearshore, and offshore resources as appropriate and incorporate automation into delivery activities.
Maintain high-quality documentation standards across engagements.