Senior Analyst, CSV / ERP

JOB DESCRIPTION OVERVIEW
CREO Senior Analysts in IT Compliance and Quality take on a proactive, hands-on role collaborating with senior staff to help clients navigate complex regulatory requirements while enabling modern, efficient IT solutions. This role requires independent execution, ownership of key workstreams, and delivery of high-quality, client-ready CSV deliverables.

Senior Analysts are highly motivated, self-directed professionals with strong technical, analytical, and communication skills. In this role, you will independently manage IT compliance-focused workstreams, distill complex regulatory and technical concepts into actionable insights, and support technology transformations across the life sciences industry.

This role is based in US Eastern time zone and collaboration with EU partners and stakeholders will require a flexible working schedule. Some travel may be required.

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.

2. 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.

3. 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.

4. 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.

• 3 to 5+ years of consulting experience or equivalent work experience in IT compliance within the life sciences industry.
• 1+ years of experience validating Oracle Cloud applications supporting manufacturing and distribution, GMP, GDP (Good Distribution Practices) is an essential requirement.
• 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).
• 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.
• 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.
• Preference given to candidates in US Eastern Time Zone

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