[Hiring] Senior Analyst - IT Quality and Compliance @CREO

Role Description

CREO Senior Analysts in IT Quality and Compliance 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 Computerized System Validation (CSV) deliverables.

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

This role will serve clients nationally and preferably be based in one of the US life science hubs (ideally the Research Triangle Park NC or Boston MA and alternatively San Diego or San Francisco CA).

Qualifications

• 3 to 5+ years of consulting experience or equivalent work experience in IT compliance within the life sciences industry.
• Experience in 2 or more regulated life science domains e.g., GCP, GMP, GLP, GDP, PV, etc.
• Experience with IT compliance or CSV in at least 2 to 3 life science functions (e.g., Medical Device software, Clinical, Quality, Supply Chain/Manufacturing, Pharmacovigilance, Labs, etc.).
• Experience with several leading software brands used extensively in life sciences (such as SAS, Veeva, TrackWise, MasterControl, Medidata, ZenQMS, Labvantage, Labware, Sapio, Benchling, Blue Mountain, BatchMaster, SAP, NetSuite, MS Dynamics, etc.).
• Experience with qualification of infrastructure for GxP use is an advantage.
• Bachelor’s degree in a relevant field (e.g., Computer Science, Information Systems, or a Life Sciences discipline).
• 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.

Requirements

• Lead and manage IT compliance and quality projects.
• Deliver client engagements focused on IT compliance, including but not limited to FDA, EU EMA, and other global health authority regulations, privacy regulations (GDPR, CCPA, etc.) or CAP/CLIA regulations.
• Oversee the end-to-end lifecycle of IT compliance projects, from initial assessment and requirements gathering to implementation, validation, and post-implementation support.
• Lead technical discussions, document key compliance decisions, and track action items.
• Ensure that projects meet client expectations, are completed on time, and align with relevant regulations and industry best practices.
• Maintain personal billable utilization at the rate of 1700 hours per year.
• 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 in the IT domain.
• Develop formal systems validation documentation (e.g., Validation Plans, Requirements/Specifications, Risk Assessments, Test Plans, Trace Matrices, etc.).
• 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.
• 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.
• 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.
• Manage and communicate complex IT compliance concepts to both technical and non-technical audiences.
• 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.

Company Description