Consultant (CSV SAP S/4HANA)

JOB DESCRIPTION OVERVIEW
As a Consultant (IT Quality and Compliance), you will play a pivotal role in helping clients navigate complex regulatory landscapes and ensure compliance within their IT systems and processes. Leveraging your deep expertise in IT compliance and the regulatory requirements of the life sciences industry across various GxP domains, you will take ownership of compliance strategy projects, lead teams, and deliver impactful solutions that mitigate risk and ensure data integrity. This position requires a business-first mindset, focusing on delivering compliance solutions that also support and enhance business objectives. This role offers significant autonomy to manage client engagements and the opportunity to expand business development efforts, helping to position the firm as a trusted partner for IT compliance solutions. You will also be responsible for driving IT compliance-focused business development and fostering relationships with key stakeholders in the life sciences and healthcare sectors.

This role is based in US Pacific time zone with primary work location on-site in Orange County, CA with potential for some remote. This role will be responsible for leading a validation of SAP S/4HANA including integrations and data migration.

POSITION RESPONSIBILITIES

1. Lead and manage IT compliance and quality projects

• Lead and manage client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, as well as privacy regulations (GDPR, CCPA, etc.).
• Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support. This includes Computer Systems Validation (CSV) and, importantly, applying modern approaches to Computer Software Assurance (CSA).
• Lead technical discussions, document key compliance decisions, and track action items.
• Manage and mentor junior staff, ensuring that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices (including 21 CFR Part 11, EU Annex 11), emphasizing true risk-based approaches to validation.
• Maintain personal billable utilization at the rate of 1700 hours per year.
• Perform IT vendor audits according to applicable standards.

1. Develop compliance-focused client deliverables.

• Create high-quality, client-ready deliverables that communicate complex IT compliance requirements and solutions in a clear and compelling way.
• Utilize advanced skills in Excel and PowerPoint to develop detailed compliance roadmaps, IT strategy documents, system validation plans, and risk assessments.
• Design technology presentations and reports that articulate business value and demonstrate how the proposed solutions will address client compliance challenges, improve data integrity, and mitigate risks.
• Develop Policies, Procedures, Forms, and Templates to drive regulatory compliance.
• Develop formal systems validation documentation.
• Leverage Automated Testing Tools to enable repeatable testing of SAP or other systems.

1. Assist clients to improve and modernize their approaches to IT compliance

• Lead data collection, IT analysis, and assessments related to IT compliance and Data Integrity.
• Take the lead in gathering data and conducting analyses to understand and remediate client compliance challenges.
• Conduct system audits, evaluate IT systems for compliance gaps, assess data integrity risks, and identify opportunities for compliance improvement and automation.
• Assist customers to evaluate and/or implement technologies that automate compliance tasks, including ALM/VLM solutions or automated testing software, as well as ITSM solutions to manage change control.
• Design technology solutions and architectures that meet regulatory requirements and incorporate best practices for data governance and security.
• Develop sophisticated models for assessing IT compliance, cost structures, and risk mitigation.
• Experience with qualification and/or validation of on-premise and cloud-based infrastructure and applications, including SaaS.
• Manage and communicate complex IT compliance concepts to both technical and non-technical audiences; this will be critical to driving project success and ensuring that client expectations are consistently met or exceeded.

1. Contribute to business development.
   • Actively contribute to business development activities by identifying IT compliance opportunities within existing client relationships and helping to acquire new clients.
   • Conduct compliance assessments, prepare proposals for IT compliance solutions, and contribute to the firm's position as a leader in IT compliance within the life sciences industry.
   • Foster relationships with senior IT and Quality executives and influence decision-makers; this will be crucial to driving revenue growth and expanding the firm's IT compliance consulting offerings.

REQUIRED QUALIFICATIONS, SKILLS, AND EXPERIENCE

• 5+ years of experience in IT compliance/CSV within the life sciences industry with significant client-facing consulting experience.
• Experience validating SAP S/4HANA including integrations and data migration is an essential requirement.
• Experience with use of Automated Testing tools
• Experience with Veeva, Trackwise or other EDMS/EQMS/Clinical Systems is desired
• Experience with additional system types across an additional GxP domain - e.g GLP, GCP, GVP (Good Pharmacovigilance Practices)
• Experience with qualification of infrastructure for GxP use is an advantage
• Experience with Lab systems is an advantage.
• Bachelor's degree in a relevant field (e.g., Computer Science, Information Systems, or a Life Sciences discipline).
• Preferred: Master's or equivalent postgraduate degree (or postgraduate degree in process).
• Leadership skills with experience managing IT or Quality teams and mentoring junior staff in a compliance-focused environment.
• Proven ability to design and implement solutions that drive compliance, mitigate risk, and provide business value.
• Advanced expertise in Excel, PowerPoint, Word, and Outlook, with extensive experience creating IT-related models, roadmaps, and presentations for compliance.
• Deep understanding of regulations and standards relevant to the life sciences industry at the intersections of Technology, Quality, Privacy and Compliance including but not limited to:
  • 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • SDLC and custom software development
  • Computer Systems Validation (CSV), Computer Software Assurance (CSA) and modern validation methodologies
  • Familiarity with FDA regulations, as applicable to automated business processes
  • Familiarity with EU EMA regulations, as applicable to automated business processes
  • Data Integrity including ALCOA+
  • Experience with validation of Software in or as Medical Devices is a plus
• Exceptional verbal and written communication skills, with the ability to present complex compliance concepts to senior-level stakeholders.
• Strong analytical skills, with the ability to evaluate technical systems and recommend improvements that enhance compliance and data integrity, while considering business needs.
• Experience in contributing to business development activities, including proposal framing, building strong client relationships, and identifying new IT compliance service opportunities.

Please note: This application may be reviewed in part by automated systems to help identify qualified candidates.