Life Sciences ERP Risk Transformation Advisory Manager

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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 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 RSMs 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 RSMs 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 RSMs 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

• Bachelors degree required.
• 5 years of relevant professional experience in ERP transformation program risk management technology risk regulatory compliance life sciences consulting or a related area.
• Experience supporting large-scale transformation programs and a strong understanding of the software development lifecycle.
• Experience with FDA validation readiness CSA/CSV GxP or similar regulated technology environments.
• Experience managing projects workstreams or engagement teams.
• Relevant professional certification preferred based on area of specialization.

Standards of Performance

• Self-starter with a process improvement mindset who is hands-on results-oriented and leads by example.
• Demonstrates an entrepreneurial mindset and high standards of professional integrity and ethics.
• Strong organizational skills with the ability to prioritize multiple projects responsibilities and deadlines.
• Ability to interact effectively with all levels of client stakeholders including executives and senior managers.
• Strong business ethics and willingness to adhere to professional standards.
• Ability to adapt to changing client priorities and meet critical deadlines when necessary.

At RSM we offer a competitive benefits and compensation package for all our more about our total rewards at 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/ 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 or send us an email at .

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 employees 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.

Required Experience:

Manager